2020-09-27 17:04:54 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Paul Mango [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Sun, 27 Sep 2020 13:04:54 -0400 

Steve- can I give you a call late this afternoon? Couple clarification questions about EUA guidance 

FDA-OC_FOl_2020-6423_001970 
2020-09-27 17:05:50 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Paul Mango [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Sun, 27 Sep 2020 13:05:50 -0400 

Sure 

FDA-OC_FOl_2020-6423_001971 
2020-09-28 16:51 :36 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Paul Mango [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Mon, 28 Sep 2020 12:51 :36 -0400 

Steve- I had one follow up question whenever you have a minute 

FDA-OC_FOl_2020-6423_001972 
2020-09-29 16:10:41 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Paul Mango [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 29 Sep 2020 12:10:41 -0400 

Any follow up? 

FDA-OC_FOl_2020-6423_001973 
2020-09-29 16:30:16 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Paul Mango [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 29 Sep 2020 12:30:16 -0400 

Still waiting to hear back from Brad. He said hea€TMs on the task though 

FDA-OC_FOl_2020-6423_00197 4 
2020-09-29 16:30:40 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Paul Mango [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 29 Sep 2020 12:30:40 -0400 

Thank you so much 

FDA-OC_FOl_2020-6423_001975 
2020-09-29 16:30:45 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Paul Mango [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 29 Sep 2020 12:30:45 -0400 

Really appreciate it 

FDA-OC_FOl_2020-6423_001976 
2020-10-05 22:38:26 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Jeff Mason :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Mon, 05 Oct 2020 18:38:26 -0400 

Hey Steve. Do you know anything about the WH contact tracing (or lack thereof) after the Coney Barrett ceremony? My 

editors are asking me to match a NYT story about that (it basically says they aren't doing any.} No worries if not. Let's 

catch up this week if you're free. I'm around. 

FDA-OC_FOl_2020-6423_001977 
2020-10-05 22:40:43 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Jeff Mason :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·1 messages"> 

Date: Mon, 05 Oct 2020 18:40:43 -0400 

I don't know any details of the effort. Would love to catch up 

FDA-OC_FOl_2020-6423_001978 
2020-10-05 22:41 :55 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Jeff Mason :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Mon, 05 Oct 2020 18:41 :55 -0400 

Let's do. l'rrt__ __________________ ___(!J.)_(~)_ ______________________ _J if you have any windows to chat then. 

FDA-OC_FOl_2020-6423_001979 
2020-10-05 23:48:35 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: 

To: 

Date: 

Jeff Mason :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Mon, 05 Oct 2020 19:48:35 -0400 

Sorry to bother you with one more story. Can you confirm this on background (ie as an administration official, your name 

wouldn't be anywhere near it): 

(NYT) The F.D.A. proposed stricter guidelines for emergency approval of a coronavirus vaccine, but the White House 

chief of staff objected to provisions that would push approval past Election Day. 

FDA-OC_FOl_2020-6423_001980 
2020-10-05 23:51 :10 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Jeff Mason :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·1 messages"> 

Date: Mon, 05 Oct 2020 19:51 :10 -0400 

Can not confirm 

FDA-OC_FOl_2020-6423_001981 
2020-12-11 19:22:49 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Jeff Mason :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Fri, 11 Dec 2020 14:22:49 -0500 

Hey there. If you feel comfortable confirming the WashPost story that Meadows requested your resignation if approval did 

not come today, please ping me. Or text Y back. I'll treat it as deep background - ie as a source familiar. No pressure. 

Sending you positive vibes either way. 

FDA-OC_FOl_2020-6423_001982 
2020-11-14 23:01 :52 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) i Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: John Redd :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Rick Scott [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Stephen Hahn [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Sat, 14 Nov 2020 18:01:52 -0500 

Sen. Scott, Dr. Hahn - I just got our distributor on the line. Florida has responded (today!). So FL HAS (late but better than 

never) accepted 3890 doses. 

FDA-OC_FOl_2020-6423_001983 
2020-11-14 23:02:22 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) i Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Rick Scott [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, John Redd [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Sat, 14 Nov 2020 18:02:22 -0500 

Great news. Thx John 

FDA-OC_FOl_2020-6423_001984 
2020-11-14 23:03:17 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) i Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: John Redd :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Rick Scott [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Stephen Hahn [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Sat, 14 Nov 2020 18:03:17 -0500 

The first doses to FL will arrive Monday. 

FDA-OC_FOl_2020-6423_001985 
2020-11-14 23:48:18 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) i Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Rick Scott :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: John Redd [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Stephen Hahn [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Sat, 14 Nov 2020 18:48:18 -0500 

Thanks 

FDA-OC_FOl_2020-6423_001986 
2020-11-21 14:00:31 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) i Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: John Redd :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Rick Scott [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Stephen Hahn [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Sat, 21 Nov 2020 09:00:31 -0500 

Senato~ (b)(6) ~ please let me know if you need anything.·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·' 

FDA-OC_FOl_2020-6423_001987 
2020-11-21 15:12:05 UTC: i (b)(G) i Messages-> 

i (b)(6) ! Messages, i (b)(6) i Messages] L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- 1--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

From: Rick Scott :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: John Redd [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Stephen Hahn [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Sat, 21 Nov 2020 10:12:05 -0500 

Thanks,l _________________________________________________ (b )(6) _________________________________________________ j Thanks for getting our state the monoclonal antibodies 

FDA-OC_FOl_2020-6423_001988 
2020-11-21 21 :31 :32 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Brett Giroir [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Sat, 21 Nov 2020 16:31:32 -0500 

[ (b)(5) JI am trying to perturb the system as little as . ..oos.~JbJe.. __ Tru.s..tme .•. __ B_Yt.l.ne.e.d __ s.9-m_e __ he.l.o.from_C_ORl:t._Jt.haiL __ [·bee·n-•r1~~( 

5 

)nd : 1: caT ~~~~~ ~~ ~~i~~ ~~~h~~~ pend i ng_ ____________________________________________________________ (_~)J?.L __________________________________________________________ : 

FDA-OC_FOl_2020-6423_001989 
2020-11-22 00:03:09 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Brett Giroir [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Sat, 21 Nov 2020 19:03:09 -0500 

I'll send you the lists tonight. I had to review them. 

FDA-OC_FOl_2020-6423_001990 
2020-11-22 00:03:44 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Brett Giroir [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Sat, 21 Nov 2020 19:03:44 -0500 

Perfect. We got enough going on!!!! 

FDA-OC_FOl_2020-6423_001991 
2020-11-27 16:43:26 UTC: [ _____________________________ ___(b)(G) ________________________________ i Messages -> [3 

recipients] 

From: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan [:::::::::j~i(sf::::::::J messages">, Janice Sheehy [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Fri, 27 Nov 2020 11 :43:26 -0500 

Noted - thank you. 

Will you DNS time on Friday, 12/4? 

We will make the day light but you do have two external engagements: 10-11 AM ET (Vaccinate Your Family Conference 

Call) and 12:45-3:00 PM ET (Zoom: NAM TOWN hall on COVID-19 Vaccine for Health Care Leaders). 

FDA-OC_FOl_2020-6423_001992 
2020-12-01 21 :24:29 UTC: i ________________________________ (b)(G) _____________________________ ___i Messages -> [3 

recipients] 

From: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan [:::::::::j~i(sf::::::::J messages">, Janice Sheehy [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 01 Dec 2020 16:24:29 -0500 

Commissioner Zucker (NY State Dept of Health) has been asked by Gov. Cuomo to speak with SH today. 

Can we coordinate 15 mins with Zucker for today, after 5 pm (since WHTF is running over, we are rescheduling CTP)? 

FDA-OC_FOl_2020-6423_001993 
2020-12-01 22:26:39 UTC: i ________________________________ (b)(G) _____________________________ ___i Messages -> [3 

recipients] 

From: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan [:::::::::j~i(sf::::::::J messages">, Janice Sheehy [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 01 Dec 2020 17:26:39 -0500 

Following up on this request AAA can we try to schedule for this evening? An alternatively, tomorrow? 

FDA-OC_FOl_2020-6423_001994 
2020-12-01 22:26:54 UTC: i ________________________________ (b)(G) _____________________________ ___i Messages -> [3 

recipients] 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Keagan Lenihan [:::::::::j~i(sf::::::::J messages">, Janice Sheehy [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 01 Dec 2020 17:26:54 -0500 

It's taken care of 

FDA-OC_FOl_2020-6423_001995 
2020-12-01 22:29:36 UTC: i ________________________________ (b)(G) _____________________________ ___i Messages -> [3 

recipients] 

From: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan [:::::::::j~i(sf::::::::J messages">, Janice Sheehy [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 01 Dec 2020 17:29:36 -0500 

Thank you. 

FDA-OC_FOl_2020-6423_001996 
2020-12-01 22:57:29 UTC: i ________________________________ (b)(G) _____________________________ ___i Messages -> [3 

recipients] 

From: Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan [:::::::::j~i(sf::::::::J messages">, Janice Sheehy [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 01 Dec 2020 17:57:29 -0500 

Per Dr. Zucker's assistant, Dr. Zucker would like to speak again this evening. 

FDA-OC_FOl_2020-6423_001997 
2020-12-01 23:27:53 UTC: i ________________________________ (b)(G) _____________________________ ___i Messages -> [3 

recipients] 

From: Stephen Hahn [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Keagan Lenihan [:::::::::j~i(sf::::::::J messages">, Janice Sheehy [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Frank Olivarria :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 01 Dec 2020 18:27:53 -0500 

Done this 

FDA-OC_FOl_2020-6423_001998 
2020-04-24 19:15:28 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Fri, 24 Apr 2020 15:15:28 -0400 

HOLOGIC Panther - they have a pre-EUA. The lead reviewer provided comments last week and they replied to the 

comments yesterday but they have not yet completed their validation. For Abbott POC, no update since what we sent this 

morning. We don't expect the EUA until next week. 

FDA-OC_FOl_2020-6423_001999 
2020-04-24 20:14:11 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Fri, 24 Apr 2020 16:14:11 -0400 

Ok. Everything ok? 

FDA-OC_FOl_2020-6423_002000 
2020-04-25 12:57:12 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 25 Apr 2020 08:57:12 -0400 

You doing TF at HHS today? 

FDA-OC_FOl_2020-6423_002001 
2020-04-25 13:44:41 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 25 Apr 2020 09:44:41 -0400 

Absolutely yes 

FDA-OC_FOl_2020-6423_002002 
2020-04-25 13:45:19 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 25 Apr 2020 09:45:19 -0400 

Thx. 

FDA-OC_FOl_2020-6423_002003 
2020-04-25 19:10:40 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 25 Apr 2020 15:10:40 -0400 

I asked Jeff if he has been working with NIOSH as they update and his response: Yes, we have been working with 

N,L(?~H. So~edof the KN95s th

1

~t China a

1 

u!ho~~?d unde

1

r thei~ c~-~P§l!§l_~l~-~Y.5-t~'!l __ §l!~--f~~l~Q9_l?.Q!!l~_g!_t_h._~ __ t'.'.IJQ§!j __ t~_5-_t!r::i_g __ 0 ,.Jl\/J.1IC1.1.mav: . .1.te__ ue_.to._ooor_aua 1tv...c.o.o.tm. s_mJu.s;ar.manu .aciun•a1 _____________________________________________________ fb.HSL ______________________________ ~ : 

l·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-(b )( 5) ·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· :-·-·-·-·-·-·-·-·-·-

FDA-OC_FOl_2020-6423_002004 
2020-04-25 19:31 :22 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 25 Apr 2020 15:31 :22 -0400 

The CoS is going to check in with NIOSH too and make sure they are working with us. 

FDA-OC_FOl_2020-6423_002005 
2020-04-25 19:39:24 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 25 Apr 2020 15:39:24 -0400 

Ok 

FDA-OC_FOl_2020-6423_002006 
2020-04-25 19:54:09 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 25 Apr 2020 15:54:09 -0400 

Ok 

FDA-OC_FOl_2020-6423_002007 
2020-04-26 01 :38:52 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 25 Apr 2020 21 :38:52 -0400 

Can w(. _____________ ( b )( 5) ·-·-·-·-·-·-·-· i 

FDA-OC_FOl_2020-6423_002008 
2020-04-26 01 :39:18 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 25 Apr 2020 21 :39:18 -0400 

What? 

FDA-OC_FOl_2020-6423_002009 
2020-04-26 01 :40:00 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 25 Apr 2020 21 :40:00 -0400 

It's a new news network 

FDA-OC_FOl_2020-6423_002010 
2020-04-26 01 :40:14 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 25 Apr 2020 21 :40:14 -0400 

Oh. Ok. 

FDA-OC_FOl_2020-6423_002011 
2020-04-26 01 :40:16 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 25 Apr 2020 21 :40:16 -0400 

John Krasinski 

FDA-OC_FOl_2020-6423_002012 
2020-04-26 01 :40:23 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 25 Apr 2020 21 :40:23 -0400 

Will talk to real. 

FDA-OC_FOl_2020-6423_002013 
2020-04-26 01 :40:26 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 25 Apr 2020 21 :40:26 -0400 

Team 

FDA-OC_FOl_2020-6423_002014 
2020-04-26 01 :40:31 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 25 Apr 2020 21 :40:31 -0400 

Love concept 

FDA-OC_FOl_2020-6423_002015 
2020-04-26 01 :40:37 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 25 Apr 2020 21 :40:37 -0400 

Some Good News = SGN 

FDA-OC_FOl_2020-6423_002016 
2020-04-26 01 :40:50 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 25 Apr 2020 21 :40:50 -0400 

FDA-OC_FOl_2020-6423_002017 
2020-04-26 01 :41 :24 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 25 Apr 2020 21 :41 :24 -0400 

Ok. Will work with team. 

FDA-OC_FOl_2020-6423_002018 
2020-04-26 01 :41 :33 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 25 Apr 2020 21 :41 :33 -0400 

Have they really reached out? 

FDA-OC_FOl_2020-6423_002019 
2020-04-26 01 :42:27 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 25 Apr 2020 21 :42:27 -0400 

No I'm watching it now 

FDA-OC_FOl_2020-6423_002020 
2020-04-26 01 :42:48 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 25 Apr 2020 21 :42:48 -0400 

We should do convalescent plasma 

FDA-OC_FOl_2020-6423_002021 
2020-04-26 01 :43:07 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 25 Apr 2020 21 :43:07 -0400 

Oh. Will get team to look into and pitch. 

FDA-OC_FOl_2020-6423_002022 
2020-04-26 01 :44:12 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 25 Apr 2020 21 :44:12 -0400 

I asked Colin to DM on Twitter 

FDA-OC_FOl_2020-6423_002023 
2020-04-26 01 :45:19 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 25 Apr 2020 21 :45:19 -0400 

Ok 

FDA-OC_FOl_2020-6423_002024 
2020-04-27 12:46:55 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 27 Apr 2020 08:46:55 -0400 

Did you see a email from Dr Birx at 7:53 

FDA-OC_FOl_2020-6423_002025 
2020-04-27 12:47:01 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 27 Apr 2020 08:47:01 -0400 

Needs urgent review. 

FDA-OC_FOl_2020-6423_002026 
2020-04-27 12:52:07 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 27 Apr 2020 08:52:07 -0400 

It's already done 

FDA-OC_FOl_2020-6423_002027 
2020-04-27 14:24:06 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 27 Apr 2020 10:24:06 -0400 

Brady hasn't gotten back to me. She said she would call after her next meeting. 

FDA-OC_FOl_2020-6423_002028 
2020-04-27 14:30:39 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 27 Apr 2020 10:30:39 -0400 

Ok 

FDA-OC_FOl_2020-6423_002029 
2020-04-27 14:33:25 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 27 Apr 2020 10:33:25 -0400 

Brady just texted. She thinks she just want to talk testing 

FDA-OC_FOl_2020-6423_002030 
2020-04-27 14:33:33 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 27 Apr 2020 10:33:33 -0400 

Ok 

FDA-OC_FOl_2020-6423_002031 
2020-04-27 17:50:44 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 27 Apr 2020 13:50:44 -0400 

Colin sent testing talkers. 

FDA-OC_FOl_2020-6423_002032 
2020-04-28 14:30:55 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 28 Apr 2020 10:30:55 -0400 

Sir- no downtime on the itinerary we got from VP office to connect with Dr. Patel. We will let their office know. 

FDA-OC_FOl_2020-6423_002033 
2020-04-28 14:32:01 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 28 Apr 2020 10:32:01 -0400 

Okth 

FDA-OC_FOl_2020-6423_002034 
2020-04-28 15:21 :13 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 28 Apr 2020 11:21:13-0400 

,·-·-Sir:.._there.Js_.anothe.Ln[eoJnLWH.m.eetina,tomorrow with AMA at 9:30am. Do you want td (b)(5) i 

[_ ____________________________________ ( b )( 5) ·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-_r '-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

FDA-OC_FOl_2020-6423_002035 
2020-04-28 19:32:53 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 28 Apr 2020 15:32:53 -0400 

Patrizia is pushing. They all recognize the importance. They are concurrently working on EUA and NDA. But they really 

haven't seen any data. 

FDA-OC_FOl_2020-6423_002036 
2020-04-28 19:33:05 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 28 Apr 2020 15:33:05 -0400 

The good news is the EUA is there so they have something to work off of. 

FDA-OC_FOl_2020-6423_002037 
2020-04-28 19:33:31 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 28 Apr 2020 15:33:31 -0400 

Of SNS takes the donation though , it will take time for BARDA to put together and EUA and start from scratch. 

FDA-OC_FOl_2020-6423_002038 
2020-04-28 19:45:01 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 28 Apr 2020 15:45:01 -0400 

Ok 

FDA-OC_FOl_2020-6423_002039 
2020-04-28 20:53:17 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 28 Apr 2020 16:53:17 -0400 

Can you arrange a call at 7:30 re: remdesivir Azar, Hahn, Amin, Keagan, Charrow, Woodcock and Kadelick? 

FDA-OC_FOl_2020-6423_002040 
2020-04-28 21 :46:06 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 28 Apr 2020 17:46:06 -0400 

EUA from CDER for Remdesivir likely ready Friday, but will let Gilead know they will approve Friday 

FDA-OC_FOl_2020-6423_002041 
2020-04-28 21 :46:14 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 28 Apr 2020 17:46:14 -0400 

Let them know tomorrow. 

FDA-OC_FOl_2020-6423_002042 
2020-04-28 22:01 :09 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 28 Apr 2020 18:01 :09 -0400 

Thx 

FDA-OC_FOl_2020-6423_002043 
2020-04-30 13:15:39 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Thu, 30 Apr 2020 09:15:39 -0400 

You 9:15 is the small group about back to facilities. 

FDA-OC_FOl_2020-6423_002044 
2020-04-30 13:15:50 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Thu, 30 Apr 2020 09:15:50 -0400 

I'm on 

FDA-OC_FOl_2020-6423_002045 
2020-04-30 17:36:59 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Thu, 30 Apr 2020 13:36:59 -0400 

I think we should do a press release on umbrella EUA and first NCI validation. 

FDA-OC_FOl_2020-6423_002046 
2020-04-30 17:39:29 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Thu, 30 Apr 2020 13:39:29 -0400 

L·-·-·-·-·-·-·-·-···-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-(b )( 5) ___ ~- ··-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·~----·-·-·-·-·-·-·-·-·-·-·-·-· i I have had evening calls with the Com ms 

team and Anand about this rollout. It's coming together. Will make sure it's simple and understandable. 

FDA-OC _FOl_2020-6423_00204 7 
2020-04-30 17:59:24 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Thu, 30 Apr 2020 13:59:24 -0400 

Liked 1 (b)(5) i I have had evening calls with the 

Comm·s-tea"fn·-ana"J\narfd·ao·ounniifrom:fuClt,,.s·com1ngloifetlier:-wnrmalce·-s1:i"rEfit,,.s·srrriple and understandable. " 

FDA-OC_FOl_2020-6423_002048 
2020-04-30 17:59:28 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Thu, 30 Apr 2020 13:59:28 -0400 

Liked "I think we should do a press release on umbrella EUA and first NCI validation. " 

FDA-OC_FOl_2020-6423_002049 
2020-05-01 17:05:05 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Fri, 01 May 2020 13:05:05 -0400 

Kennedy was like a dog with a bone on DPA. You handled well. 

FDA-OC_FOl_2020-6423_002050 
2020-05-01 17:08:20 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Fri, 01 May 2020 13:08:20 -0400 

Thx 

FDA-OC_FOl_2020-6423_002051 
2020-05-01 21 :04:13 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Fri, 01 May 2020 17:04:13 -0400 

.--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·· 

_____ Q.LBAJs_o_1,1shing back oni (b)(5) ! I have engaged Joe, but might need your helPi ____ (b){sf-·: !._ ___ ( b) ( 5 ) __ ___! L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· '·-·-·-·-·-·-·-·-·" 

FDA-OC_FOl_2020-6423_002052 
2020-05-02 20:02:21 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 02 May 2020 16:02:21 -0400 

Serology policy cleared WH. So no need t9 ___ (b)(S)___iThanks. 

FDA-OC_FOl_2020-6423_002053 
2020-05-02 20:22:37 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 02 May 2020 16:22:37 -0400 

Great. Can it be sent to me? 

FDA-OC_FOl_2020-6423_002054 
2020-05-02 21 :11 :19 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 02 May 2020 17:11:19-0400 

Will have Lauren Roth 

FDA-OC_FOl_2020-6423_002055 
2020-05-02 21 :14:12 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 02 May 2020 17:14:12 -0400 

Thx 

FDA-OC_FOl_2020-6423_002056 
2020-05-02 21 :16:10 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 02 May 2020 17: 16: 1 O -0400 

They are cleaning up edits and will send you a clean copy. 

FDA-OC_FOl_2020-6423_002057 
2020-05-02 21 :16:15 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 02 May 2020 17: 16: 15 -0400 

Thx 

FDA-OC_FOl_2020-6423_002058 
2020-05-03 13:22:42 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Sun, 03 May 2020 09:22:42 -0400 

Sir, I have a serology Comms rollout call at 9:30. Want to chat after to run through calendar? 

FDA-OC_FOl_2020-6423_002059 
2020-05-03 13:51 :49 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Sun, 03 May 2020 09:51 :49 -0400 

Sorry, I have a 10 am call. Call after that? 

FDA-OC_FOl_2020-6423_002060 
2020-05-03 13:55:31 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Sun, 03 May 2020 09:55:31 -0400 

Yep 

FDA-OC_FOl_2020-6423_002061 
2020-05-03 16:12:20 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Sun, 03 May 2020 12:12:20 -0400 

,._Saems.Jn.he . .a.hin.djsconnerLoa_~llocation and distribution of Remi.! (b)(5) i 

[_ ____________________________ ( b) ( 5) -·-·-·-·-·-·-·-·-·-·-·-·-·___: Just emailed Admiral P for info. '·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

FDA-OC_FOl_2020-6423_002062 
2020-05-04 12:37:04 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 04 May 2020 08:37:04 -0400 

Still scrambling this am on distribution. Trying to figure it out,l_ ________________________________________________________ (b )( 5) ·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-__] 

FDA-OC_FOl_2020-6423_002063 
2020-05-04 12:38:12 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 04 May 2020 08:38:12 -0400 

Ugh 

Why? 

FDA-OC_FOl_2020-6423_002064 
2020-05-04 12:38:54 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 04 May 2020 08:38:54 -0400 

No one! _________ (b)_(5) ______ J or has the expertise in house. FEMA and ASPR set up to fail here. 

FDA-OC_FOl_2020-6423_002065 
2020-05-04 12:39:04 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 04 May 2020 08:39:04 -0400 

Would have been betteL_ __________________ (b )( 5) ·-·-·-·-·-·-·-·-·-___i 

FDA-OC_FOl_2020-6423_002066 
2020-05-04 12:39:31 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 04 May 2020 08:39:31 -0400 

Ok 

FDA-OC_FOl_2020-6423_002067 
2020-05-04 12:39:46 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 04 May 2020 08:39:46 -0400 

How did you find out about the loose ends? 

FDA-OC_FOl_2020-6423_002068 
2020-05-04 12:40:37 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 04 May 2020 08:40:37 -0400 

____ ASP.R.cal.led_meJhis_am • .J..haYe..heen.on.nhone..w.itq them and Anand most of the morning. Anand trying toi (b)(5) i 

:·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ( b )( 5) -·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-___i '·-·-·-·-·-·-·-·-·-·-·-·' 

FDA-OC_FOl_2020-6423_002069 
2020-05-04 12:41 :41 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 04 May 2020 08:41 :41 -0400 

Wasn't this always i-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· { b) {_5) -·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-j 

FDA-OC_FOl_2020-6423_002070 
2020-05-04 12:42:15 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 04 May 2020 08:42:15 -0400 

___ ASPR_ doesn't_ have _clinical or_ ethical exp~rtise with_ this _d_rug ortype _of_therapy. !.,.,.,.,.,.,.,.,.,., •. ----·-·-·-·-· (b)(5) ________________________________ ! 

i_·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· (_b) ( 5) ·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· i 

FDA-OC_FOl_2020-6423_002071 
2020-05-04 12:42:33 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 04 May 2020 08:42:33 -0400 

Company doesn't want to allocate eithe{ _______________________ { b) { 4) ·-·-·-·-·-·-·-·-·-·-·-j 

FDA-OC_FOl_2020-6423_002072 
2020-05-04 12:44:07 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 04 May 2020 08:44:07 -0400 

Ok I get it. But we'll also need Deb B's input 

FDA-OC_FOl_2020-6423_002073 
2020-05-04 12:44:28 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 04 May 2020 08:44:28 -0400 

Exactly 

FDA-OC _FOl_2020-6423_00207 4 
2020-05-04 12:49:37 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 04 May 2020 08:49:37 -0400 

Do yo~----·-·-·-·-·-·-·-·-·-·-·-·-·-· ( b )( 5) -·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-j 

FDA-OC_FOl_2020-6423_002075 
2020-05-04 12:50:43 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 04 May 2020 08:50:43 -0400 

Not yet. 

FDA-OC_FOl_2020-6423_002076 
2020-05-04 12:51 :04 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 04 May 2020 08:51 :04 -0400 

I might·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ( b) ( 5 )·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·__J Is that ok? 

FDA-OC_FOl_2020-6423_002077 
2020-05-04 14:54:34 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 04 May 2020 10:54:34 -0400 

Is the Whitaker/Birx/you call one that should includ~----·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· (b )( 5) __________________________________________ j 

FDA-OC_FOl_2020-6423_002078 
2020-05-04 14:54:49 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 04 May 2020 10:54:49 -0400 

Just Scott 

FDA-OC_FOl_2020-6423_002079 
2020-05-04 14:55:13 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 04 May 2020 10:55:13 -0400 

She will only give us one 15 min window and Scott is requesting Dx. Should I le( ____________________________ (b)(5) ____________________________ j 

FDA-OC_FOl_2020-6423_002080 
2020-05-04 14:55:30 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 04 May 2020 10:55:30 -0400 

Just have the 3 of you on the call? 

FDA-OC_FOl_2020-6423_002081 
2020-05-05 18:06:46 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 05 May 2020 14:06:46 -0400 

APHL wants to keep the call in hopes you can join. 

FDA-OC_FOl_2020-6423_002082 
2020-05-05 18:06:54 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 05 May 2020 14:06:54 -0400 

Jeff will manage if you can't. 

FDA-OC_FOl_2020-6423_002083 
2020-05-05 19:04:35 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 05 May 2020 15:04:35 -0400 

Abbott test:,ILwas . .submitted (b)(4) lmd.JhP.v.,did not test enough lay users or collect sufficient 

fingersticksL_ _____________________________ '-·-·-·-·-·-·-·-·-(oH~1r·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·· _____________ ___i 

FDA-OC_FOl_2020-6423_002084 
2020-05-05 23:07:51 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 05 May 2020 19:07:51 -0400 

https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/coronavirus-disease2019-covid-19-frequently-asked-questions#drugs 

FDA-OC_FOl_2020-6423_002085 
FDA-OC_FOl_2020-6423_002086 
2020-05-05 23:07:51 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 05 May 2020 19:07:51 -0400 

6th question down 

FDA-OC_FOl_2020-6423_002087 
2020-05-05 23:10:56 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 05 May 2020 19:10:56 -0400 

Thx 

FDA-OC_FOl_2020-6423_002088 
2020-05-06 22:40:37 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Wed, 06 May 2020 18:40:37 -0400 

Admiral P wa(_·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ( b )( 5) ·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! He confirmed he 

was ok with that? 

FDA-OC_FOl_2020-6423_002089 
2020-05-06 22:40:57 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Wed, 06 May 2020 18:40:57 -0400 

The department iit·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ( b) ( 5) -·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-j 

FDA-OC_FOl_2020-6423_002090 
2020-05-06 22:41 :14 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Wed, 06 May 2020 18:41 : 14 -0400 

I sent him the list, if you want to confirm with him from that email feel free. 

FDA-OC_FOl_2020-6423_002091 
2020-05-06 22:42:13 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Wed, 06 May 2020 18:42:13 -0400 

They want you to call Meadows on it too 

FDA-OC_FOl_2020-6423_002092 
2020-05-07 13:34:22 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Thu, 07 May 2020 09:34:22 -0400 

Reminder- serology call 

FDA-OC_FOl_2020-6423_002093 
2020-05-07 14:13:05 UTC: i (b)(G) i Messages-> 

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From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Thu, 07 May 2020 10:13:05 -0400 

Ok 

FDA-OC_FOl_2020-6423_002094 
2020-05-07 16:49:17 UTC: i (b)(G) i Messages-> 

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From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Thu, 07 May 2020 12:49:17 -0400 

1 :30 Remdesivir call with Docs and HHS. 

FDA-OC_FOl_2020-6423_002095 
2020-05-07 17:29:48 UTC: i (b)(G) i Messages-> 

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From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Thu, 07 May 2020 13:29:48 -0400 

Yes sir. 

FDA-OC_FOl_2020-6423_002096 
2020-05-08 12:08:56 UTC: i (b)(G) i Messages-> 

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From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Fri, 08 May 2020 08:08:56 -0400 

.-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-. 

Didn't make it on agenda, but I think talking aboul.__ ___ Jb )( 5) ______ Jvith Hargan is a good idea. His office oversees ASA. 

FDA-OC_FOl_2020-6423_002097 
2020-05-08 12:16:33 UTC: i (b)(G) i Messages-> 

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From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Fri, 08 May 2020 08:16:33 -0400 

Ok will do. I'm not interested in spending my day at HHS so I'll leave after the SCIF. Maybe we can move up that 

appointment 

FDA-OC_FOl_2020-6423_002098 
2020-05-08 17:41 :54 UTC: i (b)(G) i Messages-> 

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To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Fri, 08 May 2020 13:41 :54 -0400 

l·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-( b )_( 5) __ ( b) ( 6) ·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-! 

FDA-OC_FOl_2020-6423_002099 
2020-05-08 17:44:41 UTC: i (b)(G) i Messages -> 

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From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Fri, 08 May 2020 13:44:41 -0400 

I think so but will ask 

FDA-OC_FOl_2020-6423_002100 
2020-05-08 17:50:38 UTC: i (b)(G) i Messages-> 

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To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Fri, 08 May 2020 13:50:38 -0400 

Thanks. 

FDA-OC_FOl_2020-6423_002101 
2020-05-08 19:48:47 UTC: i (b)(G) i Messages-> 

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From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Fri, 08 May 2020 15:48:47 -0400 

Heidi sending all hands on quarantine to you now. 

FDA-OC_FOl_2020-6423_002102 
2020-05-10 21 :23:59 UTC: i (b)(G) i Messages-> 

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From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Sun, 10 May 2020 17:23:59 -0400 

https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/coronavirus-disease2019-covid-19-frequently-asked-questions#drugs 

FDA-OC_FOl_2020-6423_002103 
FDA-OC_FOl_2020-6423_002104 
2020-05-11 12:19:53 UTC: i (b)(G) i Messages-> 

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From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 11 May 2020 08:19:53 -0400 

Sorry, dropped call. You good? 

FDA-OC_FOl_2020-6423_002105 
2020-05-11 12:20:11 UTC: i (b)(G) i Messages-> 

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From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 11 May 2020 08:20:11 -0400 

I am good. You have what you need for HELP? 

FDA-OC_FOl_2020-6423_002106 
2020-05-11 13:03:34 UTC: i (b)(G) i Messages-> 

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From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 11 May 2020 09:03:34 -0400 

Talked to Amy about data and Meadows. She is happy td (b)(S) i NYS data being published in JAMA today L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·' 

FDA-OC_FOl_2020-6423_002107 
2020-05-11 13:03:43 UTC: i (b)(G) i Messages-> 

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From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 11 May 2020 09:03:43 -0400 

Liked "I am good. You have what you need for HELP?" 

FDA-OC_FOl_2020-6423_002108 
2020-05-11 13:04:05 UTC: i (b)(G) i Messages-> 

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From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 11 May 2020 09:04:05 -0400 

Everything she see~ (b)(5) i L---·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-' 

FDA-OC_FOl_2020-6423_002109 
2020-05-11 13:04:08 UTC: i (b)(G) i Messages-> 

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From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 11 May 2020 09:04:08 -0400 

For real???? NYS data? 

FDA-OC_FOl_2020-6423_002110 
2020-05-11 13:04:26 UTC: i (b)(G) i Messages-> 

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To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 11 May 2020 09:04:26 -0400 

Yes. Thata€TMs what she said. Want a call witl__ ______ (b)(5) _____ ___! 

FDA-OC_FOl_2020-6423_002111 
2020-05-11 13:04:28 UTC: i (b)(G) i Messages-> 

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From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 11 May 2020 09:04:28 -0400 

He wants to know about our efforts on outpatient usage 

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2020-05-11 13:04:34 UTC: i (b)(G) i Messages-> 

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To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 11 May 2020 09:04:34 -0400 

Liked a€reYes. Thata€TMs what she said. Want a call wit( _____ (b)(S) _____ J• 

FDA-OC_FOl_2020-6423_002113 
2020-05-11 13:04:57 UTC: i (b)(G) i Messages-> 

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From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 11 May 2020 09:04:57 -0400 

The folks that did the NYS data also doing outpatient, but she doesn't expect results in the next few days. 

FDA-OC_FOl_2020-6423_002114 
2020-05-11 14:54:55 UTC: i (b)(G) i Messages-> 

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To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 11 May 2020 10:54:55 -0400 

FYI for your 11 am, Gov Hogan has asked for a call with you (we have it scheduled to.marrn.wLH.e_w..ants.£.DAta . .u.se_ouL, ___ labs_for_clinical testi_ng_._Apparently we aren't set up for this, we aren't CLIA certified] (b)(5) i 

!._ _________________________ ( b) ( 5 ) ________________________ ___! '·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·· 

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2020-05-11 18:34:11 UTC: i (b)(G) i Messages-> 

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From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 11 May 2020 14:34:11 -0400 

How many PCR EUAs have been authorized? 

FDA-OC_FOl_2020-6423_002116 
2020-05-11 18:34:30 UTC: i (b)(G) i Messages-> 

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To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 11 May 2020 14:34:30 -0400 

Let me check 

FDA-OC_FOl_2020-6423_002117 
2020-05-11 18:35:57 UTC: i (b)(G) i Messages-> 

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To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 11 May 2020 14:35:57 -0400 

79 per (commercial and ldt). 12 serology. 1 antigen. 

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2020-05-11 18:47:13 UTC: i (b)(G) i Messages-> 

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To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 11 May 2020 14:47:13 -0400 

Do you want to discus~'"--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·___(b )( 5) __________________________________________ ___i 

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2020-05-11 19:10:16 UTC: i (b)(G) i Messages-> 

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To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 11 May 2020 15:10:16 -0400 

Do we need to flag the fad (b)(5) ~ L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-) 

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2020-05-11 19:19:21 UTC: i (b)(G) i Messages-> 

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To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 11 May 2020 15:19:21 -0400 

Probably although we weren't involved in the decision 

FDA-OC_FOl_2020-6423_002121 
2020-05-12 17:11 :25 UTC: i (b)(G) i Messages-> 

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To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 12 May 2020 13: 11 :25 -0400 

Hearing a bit brutal today 

FDA-OC_FOl_2020-6423_002122 
2020-05-12 17:23:53 UTC: i (b)(G) i Messages-> 

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To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 12 May 2020 13:23:53 -0400 

Yep. 

FDA-OC_FOl_2020-6423_002123 
2020-05-12 17:25:39 UTC: i (b)(G) i Messages-> 

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To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 12 May 2020 13:25:39 -0400 

What is the agenda item 'coronavirus?' 

FDA-OC_FOl_2020-6423_002124 
2020-05-12 17:26:38 UTC: i (b)(G) i Messages-> 

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To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 12 May 2020 13:26:38 -0400 

I think PM is suppose to give vaccine update, Jim on inspections and Roundtable. 

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2020-05-12 17:26:48 UTC: i (b)(G) i Messages-> 

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To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 12 May 2020 13:26:48 -0400 

Not sure what Coronavirus is. 

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2020-05-12 17:27:14 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 12 May 2020 13:27:14 -0400 

What do you need? 

FDA-OC_FOl_2020-6423_002127 
2020-05-12 17:27:34 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 12 May 2020 13:27:34 -0400 

Yes I'm good for WHTF 

FDA-OC_FOl_2020-6423_002128 
2020-05-12 17:27:46 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 12 May 2020 13:27:46 -0400 

Ok. Thanks. Is JW joining? 

FDA-OC_FOl_2020-6423_002129 
2020-05-12 17:27:54 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 12 May 2020 13:27:54 -0400 

No 

FDA-OC_FOl_2020-6423_002130 
2020-05-12 18:10:41 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 12 May 2020 14:10:41 -0400 

WHTF got moved to 3pm 

FDA-OC_FOl_2020-6423_002131 
2020-05-12 18:24:27 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 12 May 2020 14:24:27 -0400 

Your background at the hearing was trending on Twitter today. Very "heavenly". Pretty funny. 

FDA-OC_FOl_2020-6423_002132 
2020-05-12 20:32:45 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 12 May 2020 16:32:45 -0400 

Still on? You have Mayo CEO call at 4:45 

FDA-OC_FOl_2020-6423_002133 
2020-05-12 20:33:23 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 12 May 2020 16:33:23 -0400 

He just wants to provide you an update about a Thermo Fisher announcement 

FDA-OC_FOl_2020-6423_002134 
2020-05-12 20:34:51 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 12 May 2020 16:34:51 -0400 

I can move it if you need me to 

FDA-OC_FOl_2020-6423_002135 
2020-05-13 19:31 :22 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Wed, 13 May 2020 15:31 :22 -0400 

FDA-OC_FOl_2020-6423_002136 
2020-05-13 19:31 :52 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Wed, 13 May 2020 15:31 :52 -0400 

After WHTF they want to do a quick prep call and then have you speak with reporter. 

FDA-OC_FOl_2020-6423_002137 
2020-05-13 20:12:20 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: 

To: 

Date: 

Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Wed, 13 May 2020 16:12:20 -0400 

;-·EDAjss..u.e.d_.an.EUAfor_these..sne.cific._druasL. _____________________________________________________________ J~l_(_~}d~.H?) _______________________________________________________________ ___l _______ , 

! (b)(3), (b)(5) I . ' 

L During the evaluation of the criteria under which to issue a'n EUA, it was' determined, based on the scientific evidence · 

available, that it is reasonable to believe that the specific drugs may be effective in treating COVID-19, and that, given 

there are no adequate, approved, or available alternative treatments, the known and potential benefits to treat this serious 

or life-threatening virus outweigh the known and potential risks when used under the conditions described in the EUA. 

Those conditions include use when a clinical trial is not available or feasible, as well as reporting requirements for 

administration under emergency use authorization. The EUA also requires that fact sheets that provide important 

information about using these drugs in treating COVID-19 be made available to health care providers and patients, 

including the known risks and drug interactions. 

FDA-OC_FOl_2020-6423_002138 
2020-05-13 20:19:09 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Wed, 13 May 2020 16:19:09 -0400 

Let me know when you can chat with them. 

FDA-OC_FOl_2020-6423_002139 
2020-05-13 21 :40:54 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Wed, 13 May 2020 17:40:54 -0400 

Do you want call with Mark from TF this week? 

FDA-OC_FOl_2020-6423_002140 
2020-05-13 22:08:58 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Wed, 13 May 2020 18:08:58 -0400 

Yes please 

FDA-OC_FOl_2020-6423_002141 
2020-05-14 15:27:52 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Thu, 14 May 2020 11 :27:52 -0400 

Do you know what the 5 pm meeting is about? 

FDA-OC_FOl_2020-6423_002142 
2020-05-14 15:28:35 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Thu, 14 May 2020 11 :28:35 -0400 

Let me check 

FDA-OC_FOl_2020-6423_002143 
2020-05-14 16:26:11 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Thu, 14 May 2020 12:26:11 -0400 

For 5pm call: ,·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·, Dr. Disbrow was asked to convene this group to present the plan for the j (b)(4), (b)(5) i 

candidate. Slide will be coming shortly. '-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·' 

FDA-OC_FOl_2020-6423_002144 
2020-05-14 16:40:28 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Thu, 14 May 2020 12:40:28 -0400 

Okthx 

FDA-OC_FOl_2020-6423_002145 
2020-05-14 20:03:45 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Thu, 14 May 2020 16:03:45 -0400 

Joining the 4? 

FDA-OC_FOl_2020-6423_002146 
2020-05-14 20:04:00 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Thu, 14 May 2020 16:04:00 -0400 

With Mark from Thermo Fisher? 

FDA-OC_FOl_2020-6423_00214 7 
2020-05-14 22:16:57 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Thu, 14 May 2020 18:16:57 -0400 

Can you hold on th{___ ____ ( b) ( 5) _______ i please? 

FDA-OC_FOl_2020-6423_002148 
2020-05-14 22:23:19 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Thu, 14 May 2020 18:23:19 -0400 

Yes. Heard from Judy. 

FDA-OC_FOl_2020-6423_002149 
2020-05-15 00:04:05 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Thu, 14 May 2020 20:04:05 -0400 

So you can just walk in and get tested? Don't need an appointment? 

FDA-OC_FOl_2020-6423_002150 
2020-05-15 00:41 :05 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Thu, 14 May 2020 20:41:05 -0400 

Peter and JW are all set for tomorrow and will be there. 

FDA-OC_FOl_2020-6423_002151 
2020-05-15 10:24:53 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Fri, 15 May 2020 06:24:53 -0400 

Multiple questions aboutj _______________________________________________ ( b) ( 5) ·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-j 

FDA-OC_FOl_2020-6423_002152 
2020-05-15 10:25:16 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Fri, 15 May 2020 06:25: 16 -0400 

Ok. Thx. 

FDA-OC_FOl_2020-6423_002153 
2020-05-15 10:35:56 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Fri, 15 May 2020 06:35:56 -0400 

On I __________________ { b ){_5) -·-·-·-·-·-·-·-·-j Got it. 

FDA-OC_FOl_2020-6423_002154 
2020-05-15 10:39:37 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Fri, 15 May 2020 06:39:37 -0400 

And how it could be used by WH 

FDA-OC_FOl_2020-6423_002155 
2020-05-15 13:16:12 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Fri, 15 May 2020 09:16:12 -0400 

Just calling you about Abbott test. AMA has questions 

FDA-OC_FOl_2020-6423_002156 
2020-05-16 12:19:25 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 16 May 2020 08: 19:25 -0400 

Do you have access to the NIOSH list for masks? 

FDA-OC_FOl_2020-6423_002157 
2020-05-16 12:58:41 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 16 May 2020 08:58:41 -0400 

I don't think so, but can ask. 

FDA-OC_FOl_2020-6423_002158 
2020-05-16 13:00:09 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 16 May 2020 09:00:09-0400 

Didn't you pass it along to FEMA? 

FDA-OC_FOl_2020-6423_002159 
2020-05-16 13:00:47 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 16 May 2020 09:00:47 -0400 

Sent them what we were pulling II think. Let me look. Will send shortly. 

FDA-OC_FOl_2020-6423_002160 
2020-05-16 13:00:59 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 16 May 2020 09:00:59-0400 

That's what I meant, sorry 

FDA-OC_FOl_2020-6423_002161 
2020-05-16 13:01 :18 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 16 May 2020 09:01:18-0400 

Gotcha. Hold one sec 

FDA-OC_FOl_2020-6423_002162 
2020-05-16 13:01 :26 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 16 May 2020 09:01 :26 -0400 

Looking for a company called __ __(b)(4) ___ i 

FDA-OC_FOl_2020-6423_002163 
2020-05-16 13:03:39 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 16 May 2020 09:03:39 -0400 

Just emailed you list. Didn't see it on there. Let me look for NIOSH and non NIOSH approved masks 

FDA-OC_FOl_2020-6423_002164 
2020-05-16 13:04:05 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 16 May 2020 09:04:05 -0400 

From meadows to Alex 

FDA-OC_FOl_2020-6423_002165 
2020-05-16 13:04:11 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 16 May 2020 09:04: 11 -0400 

Ok 

FDA-OC_FOl_2020-6423_002166 
2020-05-16 13:06:35 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 16 May 2020 09:06:35 -0400 

Let me check with Suzanne. 

FDA-OC_FOl_2020-6423_002167 
2020-05-16 13:22:44 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 16 May 2020 09:22:44 -0400 

Just forwarded you email from Suzanne. She said she downloaded with Jeff so guessing he will call you too. 

FDA-OC_FOl_2020-6423_002168 
2020-05-16 13:22:53 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 16 May 2020 09:22:53 -0400 

Thx 

FDA-OC_FOl_2020-6423_002169 
2020-05-16 13:52:31 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 16 May 2020 09:52:31 -0400 

~~z~~ni~ fe~~ i~~~~g-togetner review "today. ·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· (b )( 4 )·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· i 

FDA-OC_FOl_2020-6423_002170 
2020-05-16 18:20:21 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 16 May 2020 14:20:21 -0400 

https://www.nytimes.com/2020/05/15/us/coronavirus-testing-seattle-bill-gates.html 

FDA-OC_FOl_2020-6423_002171 
FDA-OC_FOl_2020-6423_002172 
FDA-OC_FOl_2020-6423_002173 
2020-05-16 18:20:21 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 16 May 2020 14:20:21 -0400 

Here is the story, working on getting you talkers. 

FDA-OC_FOl_2020-6423_00217 4 
2020-05-16 18:20:39 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 16 May 2020 14:20:39-0400 

OMA has been on the phone with the HHS press team working on prep materials for AMA. 

FDA-OC_FOl_2020-6423_002175 
2020-05-16 18:23:30 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 16 May 2020 14:23:30 -0400 

Ok. We still have the underlying issue to deal with 

FDA-OC_FOl_2020-6423_002176 
2020-05-16 18:23:39 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 16 May 2020 14:23:39-0400 

Yep 

FDA-OC_FOl_2020-6423_002177 
2020-05-16 18:24:08 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Sat, 16 May 2020 14:24:08-0400 

Can you put that issue on the agenda of our next call together? 

FDA-OC_FOl_2020-6423_002178 
2020-05-18 14:49:16 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 18 May 2020 10:49:16 -0400 

Fred Turner, CEO of Curative cell#, ___________ (b)(6) _______ ___: 

FDA-OC_FOl_2020-6423_002179 
2020-05-18 14:49:34 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 18 May 2020 10:49:34 -0400 

I spoke with Jeff and we agre{ ____________________ ( b) ( 5) _____________________ j 

FDA-OC_FOl_2020-6423_002180 
2020-05-18 14:50:59 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 18 May 2020 10:50:59 -0400 

L~ Yous~~~;~)call _a

nd

: ~~~y should expectto here from GDRH today.·-·-· (b )( S) -·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-1 

FDA-OC_FOl_2020-6423_002181 
2020-05-18 18:43:43 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 18 May 2020 14:43:43 -0400 

Sorry this took a while. 

Henry Ji, PhD 

Chairman, President and Chief Executive Officer 

Sorrento Therapeutics 

E-mail: Hji(,@sorrentotherapeutics.com 

Cell Phon8j ________________ (b)(6) -·-·-·-·-·-·-·-· i 

FDA-OC_FOl_2020-6423_002182 
2020-05-18 18:44:08 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 18 May 2020 14:44:08 -0400 

Do you want us to set up a call or just direct dial him yourself? 

FDA-OC_FOl_2020-6423_002183 
2020-05-18 18:46:26 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 18 May 2020 14:46:26 -0400 

I'll call 

FDA-OC_FOl_2020-6423_002184 
2020-05-18 18:46:30 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 18 May 2020 14:46:30 -0400 

Ok 

FDA-OC_FOl_2020-6423_002185 
2020-05-18 20:37:13 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 18 May 2020 16:37:13 -0400 

Anand said he just sent you a note on HCQ Comms 

FDA-OC_FOl_2020-6423_002186 
2020-05-18 20:37:56 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 18 May 2020 16:37:56 -0400 

Ok 

FDA-OC_FOl_2020-6423_002187 
2020-05-19 13:40:40 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 19 May 2020 09:40:40 -0400 

Howard Zucker called the front office line for you. Can you give him a call after CD call? i (b )(6) i 

L---·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-' 

FDA-OC_FOl_2020-6423_002188 
2020-05-19 13:40:48 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 19 May 2020 09:40:48 -0400 

Yes 

FDA-OC_FOl_2020-6423_002189 
2020-05-19 13:40:54 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 19 May 2020 09:40:54 -0400 

Thx 

FDA-OC_FOl_2020-6423_002190 
2020-05-19 14:29:46 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 19 May 2020 10:29:46 -0400 

How about for AEG: MWF with Wednesday being at 4 pm? 

FDA-OC_FOl_2020-6423_002191 
2020-05-19 14:31 :26 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 19 May 2020 10:31:26-0400 

Works for me. Any concerns with WHTF? 

FDA-OC_FOl_2020-6423_002192 
2020-05-19 14:31 :51 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 19 May 2020 10:31:51 -0400 

No 

FDA-OC_FOl_2020-6423_002193 
2020-05-19 14:31 :58 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 19 May 2020 10:31:58-0400 

I will talk to Denise. 

FDA-OC_FOl_2020-6423_002194 
2020-05-19 14:32:31 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 19 May 2020 10:32:31 -0400 

We can't continue to be held hostage by the lack of clarity 

FDA-OC_FOl_2020-6423_002195 
2020-05-19 14:32:51 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 19 May 2020 10:32:51 -0400 

Totally agree. 

FDA-OC_FOl_2020-6423_002196 
2020-05-19 17:02:53 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 19 May 2020 13:02:53 -0400 

Ok 

FDA-OC_FOl_2020-6423_002197 
2020-05-19 17:07:30 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 19 May 2020 13:07:30 -0400 

FYI- Brian Harrison, VADM Daniel Abel, CAPT Michael Barton have requested meeting with you and I at 4pm. Will try and 

get a little info about what it is. Is 4pm ok with you? 

FDA-OC_FOl_2020-6423_002198 
2020-05-19 17:17:28 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 19 May 2020 13:17:28 -0400 

Depends on the topic 

FDA-OC_FOl_2020-6423_002199 
2020-05-19 17:19:11 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 19 May 2020 13:19:11 -0400 

Who are Abel and Barton? 

FDA-OC_FOl_2020-6423_002200 
2020-05-19 17:20:14 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 19 May 2020 13:20:14 -0400 

New people that are a part of the OWS project. I think it's probably an intro call to read us in on how things will operate, 

but getting more info. 

FDA-OC_FOl_2020-6423_002201 
2020-05-19 17:20:24 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 19 May 2020 13:20:24 -0400 

Think they are from DoD 

FDA-OC_FOl_2020-6423_002202 
2020-05-19 17:20:33 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 19 May 2020 13:20:33 -0400 

Oh ok, that's fine 

FDA-OC_FOl_2020-6423_002203 
2020-05-19 17:20:38 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 19 May 2020 13:20:38 -0400 

Ok 

FDA-OC_FOl_2020-6423_002204 
2020-05-19 17:39:33 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 19 May 2020 13:39:33 -0400 

Oh, perfect. Thx. 

FDA-OC_FOl_2020-6423_002205 
2020-05-19 17:45:19 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 19 May 2020 13:45:19 -0400 

Looks like the Harrison call is tomorrow at 4 

FDA-OC_FOl_2020-6423_002206 
2020-05-19 17:48:55 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 19 May 2020 13:48:55 -0400 

Yes. They moved to to tomorrow. 

FDA-OC_FOl_2020-6423_002207 
2020-05-19 17:50:18 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 19 May 2020 13:50:18 -0400 

Liked a€reYes. They moved to to tomorrow.a€• 

FDA-OC_FOl_2020-6423_002208 
2020-05-19 17:57:07 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 19 May 2020 13:57:07 -0400 

Paul said the call tomorrow is an Introduction to VADM Abel who will be helping us coordinate internal COVID response 

as we transition activities back to HHS. We are introducing him to all key COVID related operating divisions. Doing the 

same with NIH, CDC, ASPR, CMS. He will not be working on OWS. Sounds like a project manager to coordinate HHS 

wide efforts on COVID. 

FDA-OC_FOl_2020-6423_002209 
2020-05-19 17:59:56 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 19 May 2020 13:59:56 -0400 

Great 

FDA-OC_FOl_2020-6423_002210 
2020-05-19 18:15:54 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 19 May 2020 14:15:54 -0400 

We have Brian Harrison tomorrow during the time we were going to move AEG and you have AMA meeting at 5. 

FDA-OC_FOl_2020-6423_002211 
2020-05-19 21 :16:55 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 19 May 2020 17:16:55 -0400 

Shook loose MOU. Moving forward. 

FDA-OC_FOl_2020-6423_002212 
2020-05-19 21 :18:34 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 19 May 2020 17:18:34 -0400 

Excellent. You are terrific 

FDA-OC_FOl_2020-6423_002213 
2020-05-19 21 :18:56 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 19 May 2020 17:18:56 -0400 

Team effort. Thx. 

FDA-OC_FOl_2020-6423_002214 
2020-05-19 21 :19:04 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 19 May 2020 17:19:04 -0400 

Great 

FDA-OC_FOl_2020-6423_002215 
2020-05-20 14:48:59 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Wed, 20 May 2020 10:48:59 -0400 

Did you get in touch with Henry from Sorrento? Or did you want us to set up a call. 

FDA-OC_FOl_2020-6423_002216 
2020-05-20 18:51 :01 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Wed, 20 May 2020 14:51 :01 -0400 

Also, Jeff just sent list of serology tests coming off to your email! (b )(5) ] L---·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-

FDA-OC_FOl_2020-6423_002217 
2020-05-22 14:24:30 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Fri, 22 May 2020 10:24:30 -0400 

Bill gates meeting: the request is to discuss vaccine development, as well as data around both vaccines and therapeutics. 

FDA-OC_FOl_2020-6423_002218 
2020-05-22 14:24:40 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Fri, 22 May 2020 10:24:40 -0400 

Do you want me to[_ __________ ( b )( 5) ___________ ! 

FDA-OC_FOl_2020-6423_002219 
2020-05-22 14:24:48 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Fri, 22 May 2020 10:24:48 -0400 

YES PLEASE 

FDA-OC_FOl_2020-6423_002220 
2020-05-22 14:24:52 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Fri, 22 May 2020 10:24:52 -0400 

Will do. 

FDA-OC_FOl_2020-6423_002221 
2020-05-22 16:54:16 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Fri, 22 May 2020 12:54:16 -0400 

Looks Ii kEt _______________________________________ ( b )( 5) ·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·] 

FDA-OC_FOl_2020-6423_002222 
2020-05-22 17:00:49 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Fri, 22 May 2020 13:00:49 -0400 

Ok 

FDA-OC_FOl_2020-6423_002223 
2020-05-22 17:03:58 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Fri, 22 May 2020 13:03:58 -0400 

Stacy wa{ ____ ,-·-·-·-·-·-·-·-·-·-·-·-·_(l?J(~l_ __________________________ ___! Do you need anything since the discussion is vaccines and therapeutics. 

Do you want l_ _____ ( b) ( 5) ___ ___! 

FDA-OC_FOl_2020-6423_002224 
2020-05-22 17:04:41 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Fri, 22 May 2020 13:04:41 -0400 

Apparently, the call he had with the Dept about testing he wasn't very pleasant. 

FDA-OC_FOl_2020-6423_002225 
2020-05-22 17:06:12 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Fri, 22 May 2020 13:06:12 -0400 

I'll do it alone. They don't need the hassle 

FDA-OC_FOl_2020-6423_002226 
2020-05-22 17:13:13 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Fri, 22 May 2020 13:13:13 -0400 

Ok. 

FDA-OC_FOl_2020-6423_002227 
2020-05-22 17:47:41 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Fri, 22 May 2020 13:47:41 -0400 

___ Sir •. iba.3.nmJs.JnllQw up with OCC and Anand on[ (b)(5) !and also Stacy and Anand need to discuss some 

[ _______________ ( b )( 5) ·-·-·-·-·-·-· ! '·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-

FDA-OC_FOl_2020-6423_002228 
2020-05-25 16:15:01 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 25 May 2020 12:15:01 -0400 

Back to offices update? 

FDA-OC_FOl_2020-6423_002229 
2020-05-25 16:15:07 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 25 May 2020 12:15:07 -0400 

Sounds good. 

FDA-OC_FOl_2020-6423_002230 
2020-05-25 16:19:26 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 25 May 2020 12:19:26 -0400 

WHTF likely to be Tuesday and Thursday. Can we mov{ ___________________________________ {_b }_{ 5} ·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-.I 

FDA-OC_FOl_2020-6423_002231 
2020-05-25 16:19:45 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 25 May 2020 12:19:45 -0400 

Will ask Janice. 

FDA-OC_FOl_2020-6423_002232 
2020-05-25 16:20:06 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 25 May 2020 12:20:06 -0400 

Thx 

FDA-OC_FOl_2020-6423_002233 
2020-05-27 16:59:19 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Wed, 27 May 2020 12:59:19 -0400 

FYI- JW sounds like she is really struggling with OWS. Seems like it's a cluster. 

FDA-OC_FOl_2020-6423_002234 
2020-05-27 17:09:06 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Wed, 27 May 2020 13:09:06 -0400 

You wanted to do Gates call solo, right? !-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-{_b ){ 5) ·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-___i 

FDA-OC_FOl_2020-6423_002235 
2020-05-27 17:09:19 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Wed, 27 May 2020 13:09:19 -0400 

Right 

FDA-OC_FOl_2020-6423_002236 
2020-05-27 17:09:45 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Wed, 27 May 2020 13:09:45 -0400 

Thx 

FDA-OC_FOl_2020-6423_002237 
2020-05-27 17:10:00 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Wed, 27 May 2020 13:10:00 -0400 

When is it? 

FDA-OC_FOl_2020-6423_002238 
2020-05-27 17:10:06 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Wed, 27 May 2020 13:10:06 -0400 

Tomorrow 

FDA-OC_FOl_2020-6423_002239 
2020-05-28 00:27:29 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Wed, 27 May 2020 20:27:29 -0400 

Yes for Gates. l_ _______________________ __(b )(5) -·-·-·-·-·-·-·-·-·-·-·-·-·j 

FDA-OC_FOl_2020-6423_002240 
2020-05-28 00:32:01 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Wed, 27 May 2020 20:32:01 -0400 

Thx 

FDA-OC_FOl_2020-6423_002241 
2020-05-28 23:32:04 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Thu, 28 May 2020 19:32:04 -0400 

Jeff called on! (b)(4) !Did you connect? If not, happy to chat. j_ ___________ j 

FDA-OC_FOl_2020-6423_002242 
2020-05-29 00:45:18 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Thu, 28 May 2020 20:45:18 -0400 

Jeff and l (b)(4J_i? 

FDA-OC_FOl_2020-6423_002243 
2020-05-29 00:46:18 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Thu, 28 May 2020 20:46:18 -0400 

r·-~(~~ ~an 't make th IS . up.-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ( b) ( 4) ·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· : 

FDA-OC_FOl_2020-6423_002244 
2020-05-29 00:46:55 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Thu, 28 May 2020 20:46:55 -0400 

Seriously? 

FDA-OC_FOl_2020-6423_002245 
2020-05-29 00:47:12 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Thu, 28 May 2020 20:47:12 -0400 

["-~-~~-g1i~4jitJ:l~:--r~:~ 't ·make . th is· up .. ,,-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· (b )( 

4

) ·-·-·-·-·-·--·-·-·-·-·-·-·--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·--·-·-·-·-·-·--·-·-·___! 

FDA-OC_FOl_2020-6423_002246 
2020-05-29 00:47:18 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Thu, 28 May 2020 20:47:18 -0400 

Yep. He!_ ______________________________________________________ __(b )(5) -·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ito have a response. 

FDA-OC _FOl_2020-6423_00224 7 
2020-05-29 00:47:33 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Thu, 28 May 2020 20:47:33 -0400 

Ok let's talk with n AM 

FDA-OC_FOl_2020-6423_002248 
2020-05-29 00:47:40 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Thu, 28 May 2020 20:47:40 -0400 

I am going to get CDRH, OP and OCC together to discuss. And get back to you 

FDA-OC_FOl_2020-6423_002249 
2020-05-29 00:48:00 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Thu, 28 May 2020 20:48:00 -0400 

Happy to discuss tomorrow. 

FDA-OC_FOl_2020-6423_002250 
2020-05-29 13:44:50 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Fri, 29 May 2020 09:44:50 -0400 

Feedback session right 

FDA-OC_FOl_2020-6423_002251 
2020-05-29 13:45:06 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Fri, 29 May 2020 09:45:06 -0400 

That is my understanding. Anything you need? 

FDA-OC_FOl_2020-6423_002252 
2020-05-29 13:45:06 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Fri, 29 May 2020 09:45:06 -0400 

No specific agenda, right? 

FDA-OC_FOl_2020-6423_002253 
2020-05-29 13:45:14 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Fri, 29 May 2020 09:45:14 -0400 

Will send what I have. 

FDA-OC_FOl_2020-6423_002254 
2020-05-29 13:45:17 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Fri, 29 May 2020 09:45: 17 -0400 

Nope just want to understand 

FDA-OC_FOl_2020-6423_002255 
2020-05-29 13:49:06 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Fri, 29 May 2020 09:49:06 -0400 

FDA-OC_FOl_2020-6423_002256 
Memorandum 

To: Dr.Hahn 

From: OEA Stakeholder Team 

Re: PhRMA CEO call re COVID-19 Vaccines on Friday, May 29th, 2020 

Below please find your talking points and the agenda items PhRMA would like to discuss 

during the call tomorrow. Also, BIO may have a few attendees as well, but we are still waiting 

on confirmation from them. 

Joining you for this call from FDA: 

Dr. Peter Marks, Director, CBER 

Agenda 

Welcome/Opening Remarks 

Summary Industry Updates 

Topics for Discussion: 

Commissioner Stephen Hahn 

Dr. Peter Marks 

Vas N arasimhan/N ovartis/PhRMA 

Vas Narasimhan/Novartis (moderator) 

1. Globalization and harmonization of clinical development and regulatory review 

2. Risk-based regulatory guidance and expectations for GMP issues associated with vaccine 

manufacturing 

FDA-OC_FOl_2020-6423_002257 
3. Criteria for and timing of inclusion of pediatric subjects in coronavirus vaccine clinical 

studies 

Opening Remarks Stephen Hahn, FDA Commissioner 

FDA-OC_FOl_2020-6423_002258 
FDA-OC_FOl_2020-6423_002259 
2020-06-01 18:56:39 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 01 Jun 2020 14:56:39 -0400 

lsna€TMt that DoDs role in all this? 

FDA-OC_FOl_2020-6423_002260 
2020-06-01 18:56:45 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 01 Jun 2020 14:56:45 -0400 

Yes 

FDA-OC_FOl_2020-6423_002261 
2020-06-01 18:56:46 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 01 Jun 2020 14:56:46 -0400 

Project management and leadership 

FDA-OC_FOl_2020-6423_002262 
2020-06-01 18:57:11 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 01 Jun 2020 14:57:11 -0400 

Helpful context for your call with the general 

FDA-OC_FOl_2020-6423_002263 
2020-06-01 18:57:19 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 01 Jun 2020 14:57:19 -0400 

Liked "Helpful context for your call with the general" 

FDA-OC_FOl_2020-6423_002264 
2020-06-02 12:55:45 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 02 Jun 2020 08:55:45 -0400 

.·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·1 

And add to CDRH agenda: development o( __________________________ j~){§J_ ____________________________ _j 

FDA-OC_FOl_2020-6423_002265 
2020-06-02 12:56:48 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 02 Jun 2020 08:56:48 -0400 

Will do. 

FDA-OC_FOl_2020-6423_002266 
2020-06-02 12:58:23 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 02 Jun 2020 08:58:23 -0400 

Thx 

FDA-OC_FOl_2020-6423_002267 
2020-06-02 16:30:38 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 02 Jun 2020 12:30:38 -0400 

Apparently it wasn't leaked docs, it was a FOIA response for the decision memo on hydroxychloroquine EUA. Reporters 

didn't reach out. Michael is sending to you now. 

FDA-OC_FOl_2020-6423_002268 
2020-06-02 16:35:19 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 02 Jun 2020 12:35:19 -0400 

Joining recovery and review? 

FDA-OC_FOl_2020-6423_002269 
2020-06-02 20:07:58 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 02 Jun 2020 16:07:58 -0400 

Nuclei~----·-·-·-·-·-·-·-·(b )( 4) ·-·-·-·-·-·-·-·-·-j 

FDA-OC_FOl_2020-6423_002270 
2020-06-02 23:28:22 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 02 Jun 2020 19:28:22 -0400 

Yep. I emailed OP about_ _____ (b )(_5) _____ jsounds like Anand is working similar 

FDA-OC_FOl_2020-6423_002271 
2020-06-02 23:29:41 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 02 Jun 2020 19:29:41 -0400 

Jeff and I need to lay eyes on it 

FDA-OC_FOl_2020-6423_002272 
2020-06-02 23:29:51 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 02 Jun 2020 19:29:51 -0400 

Ok. 

FDA-OC_FOl_2020-6423_002273 
2020-06-02 23:29:58 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 02 Jun 2020 19:29:58 -0400 

It's with Jeff. He is asking for more time. 

FDA-OC _FOl_2020-6423_00227 4 
2020-06-02 23:30:05 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 02 Jun 2020 19:30:05 -0400 

I just asked HHS for more time. 

FDA-OC_FOl_2020-6423_002275 
2020-06-02 23:31 :45 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 02 Jun 2020 19:31 :45 -0400 

Yes, give him the time he needs 

FDA-OC_FOl_2020-6423_002276 
2020-06-02 23:32:01 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 02 Jun 2020 19:32:01 -0400 

Deb Bir>< is aware of our review 

FDA-OC_FOl_2020-6423_002277 
2020-06-02 23:32:13 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 02 Jun 2020 19:32:13 -0400 

Ok. Pushing. wi(_ __________________________ (b )( 5) -·-·-·-·-·-·-·-·-·-·-·-·___i 

FDA-OC_FOl_2020-6423_002278 
2020-06-03 01 :51 :44 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 02 Jun 2020 21 :51 :44 -0400 

Got Jeff till 2pm tomorrow, which he said ok to. Pis provide your feedback before 2 if you can. Thanks. 

FDA-OC_FOl_2020-6423_002279 
2020-06-03 13:02:43 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Wed, 03 Jun 2020 09:02:43 -0400 

Wow, the Secretary this AM. I'm concerned he's on fire 

FDA-OC_FOl_2020-6423_002280 
2020-06-03 13:03:17 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Wed, 03 Jun 2020 09:03:17 -0400 

Uh oh. On testing? 

FDA-OC_FOl_2020-6423_002281 
2020-06-03 13:04:19 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Wed, 03 Jun 2020 09:04:19 -0400 

In general. He's trying to reassert control but has trouble treating all of us adults 

FDA-OC_FOl_2020-6423_002282 
2020-06-03 13:04:48 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Wed, 03 Jun 2020 09:04:48 -0400 

Not helpful 

FDA-OC_FOl_2020-6423_002283 
2020-06-03 14:28:09 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Wed, 03 Jun 2020 10:28:09 -0400 

Anything else you want to discuss? 

FDA-OC_FOl_2020-6423_002284 
2020-06-03 14:28:31 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Wed, 03 Jun 2020 10:28:31 -0400 

Back to office update? 

FDA-OC_FOl_2020-6423_002285 
2020-06-03 15:24:44 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Wed, 03 Jun 2020 11 :24:44 -0400 

Just to double check, with yours and Jeff's edits to the document we are ok to concur with this document? 

FDA-OC_FOl_2020-6423_002286 
2020-06-03 15:25:10 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Wed, 03 Jun 2020 11:25:10-0400 

I am just double check with Jeff 

FDA-OC_FOl_2020-6423_002287 
2020-06-03 15:29:46 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Wed, 03 Jun 2020 11 :29:46 -0400 

Ok 

FDA-OC_FOl_2020-6423_002288 
2020-06-03 15:53:01 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Wed, 03 Jun 2020 11 :53:01 -0400 

Did he get back to you? 

FDA-OC_FOl_2020-6423_002289 
2020-06-03 15:53:07 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Wed, 03 Jun 2020 11 :53:07 -0400 

I have to let them know by noon. 

FDA-OC_FOl_2020-6423_002290 
2020-06-03 15:53:55 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Wed, 03 Jun 2020 11 :53:55 -0400 

He sent me his comments but didn't answer the concur question. Can you query him? 

FDA-OC_FOl_2020-6423_002291 
2020-06-03 15:54:03 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Wed, 03 Jun 2020 11 :54:03 -0400 

Yes 

FDA-OC_FOl_2020-6423_002292 
2020-06-03 16:00:01 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Wed, 03 Jun 2020 12:00:01 -0400 

____ .Frrun..Jaff :-:..Bn.e.to_send.m.v:.c.omments .•. C.ons.ideLtbem.tecbnicaLcomments..i ___________________________________ Jt>.K~L. ______________________________ __L ______________ _ 

I {b){5) I 

i-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-i 

FDA-OC_FOl_2020-6423_002293 
2020-06-03 16:00:24 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Wed, 03 Jun 2020 12:00:24 -0400 

Do you concur? 

FDA-OC_FOl_2020-6423_002294 
2020-06-03 16:00:43 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Wed, 03 Jun 2020 12:00:43 -0400 

Concur 

FDA-OC_FOl_2020-6423_002295 
2020-06-03 16:01 :01 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Wed, 03 Jun 2020 12:01 :01 -0400 

Thx 

FDA-OC_FOl_2020-6423_002296 
2020-06-04 13:09:12 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Thu, 04 Jun 2020 09:09:12 -0400 

Do you want to chat vaccine email with Anand and I now? 

FDA-OC_FOl_2020-6423_002297 
2020-06-04 16:53:15 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Thu, 04 Jun 2020 12:53:15 -0400 

,.Anv_au.i.ck..uo_date.s __ at beginning of CD call today? Maybe mentioningi (b)(5) ! ! ___________ ( b) ( 5 ) ___________ i L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·' 

FDA-OC_FOl_2020-6423_002298 
2020-06-04 16:59:35 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Thu, 04 Jun 2020 12:59:35 -0400 

I think I' II hold off on l·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ( b) ( 5) _·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! 

FDA-OC_FOl_2020-6423_002299 
2020-06-04 16:59:42 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Thu, 04 Jun 2020 12:59:42 -0400 

Ok 

FDA-OC_FOl_2020-6423_002300 
2020-06-08 14:30:13 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 08 Jun 2020 10:30:13 -0400 

Curious how much HCQ ASPR still has under the EUA. I will check. 

FDA-OC_FOl_2020-6423_002301 
2020-06-08 19:02:17 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 08 Jun 2020 15:02:17 -0400 

It was a good call until we started talking about HQ 

FDA-OC_FOl_2020-6423_002302 
2020-06-08 19:02:39 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 08 Jun 2020 15:02:39 -0400 

Uh oh. 

FDA-OC_FOl_2020-6423_002303 
2020-06-08 19:38:55 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Mon, 08 Jun 2020 15:38:55 -0400 

Finalizing current rule and working like crazy on COVID 

FDA-OC_FOl_2020-6423_002304 
2020-06-09 12:25:10 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 09 Jun 2020 08:25:10 -0400 

Any update on the CDC guidance? 

FDA-OC_FOl_2020-6423_002305 
2020-06-09 12:25:33 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 09 Jun 2020 08:25:33 -0400 

Lowell and Lauren didn't know what it was. Have an email into CDRH. 

FDA-OC_FOl_2020-6423_002306 
2020-06-09 12:36:51 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 09 Jun 2020 08:36:51 -0400 

How is that possible? We need to get Anand and Anna on the phone and figure out this guidance clearance process. It 

seems very disjointed 

FDA-OC_FOl_2020-6423_002307 
2020-06-09 12:37:30 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 09 Jun 2020 08:37:30 -0400 

Will call Anna. 

FDA-OC_FOl_2020-6423_002308 
2020-06-09 12:41 :27 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 09 Jun 2020 08:41 :27 -0400 

Anna didn't know and hasn't seen. I am calling Anand now. 

FDA-OC_FOl_2020-6423_002309 
2020-06-09 12:41 :39 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 09 Jun 2020 08:41 :39 -0400 

Will set up a call for us to work through fixing on our end. 

FDA-OC_FOl_2020-6423_002310 
2020-06-09 12:43:53 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 09 Jun 2020 08:43:53 -0400 

Anand might know what it is, he says he had issues with CDRH on a CDC guidance Friday. Can you get me the title and 

he can take care of it. 

FDA-OC_FOl_2020-6423_002311 
2020-06-09 12:44:39 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 09 Jun 2020 08:44:39 -0400 

Testing guidance 

FDA-OC_FOl_2020-6423_002312 
2020-06-09 12:47:17 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 09 Jun 2020 08:47:17 -0400 

It's not for farm workers is it? 

FDA-OC_FOl_2020-6423_002313 
2020-06-09 12:55:16 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 09 Jun 2020 08:55:16 -0400 

No 

FDA-OC_FOl_2020-6423_002314 
2020-06-09 12:56:46 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 09 Jun 2020 08:56:46 -0400 

From Tim Stenzel : .-·-·-·-·-·· r·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·i 

.N9.!J:l_l![~.J.Ubl~.J.~;_~!)_Ql:!.t!.~.P.Q.~JQ9-.r~su Its ofl!.?).~5)Jesti ng. Anywa(_ __________________________________________________ J~H-~L-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-___! 

L_ ___________________________ __( b )( 5) ·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! 

FDA-OC_FOl_2020-6423_002315 
2020-06-09 12:56:57 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 09 Jun 2020 08:56:57 -0400 

No one seems to know what the specific guidance is. 

FDA-OC_FOl_2020-6423_002316 
2020-06-09 13:40:00 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 09 Jun 2020 09:40:00 -0400 

The data are unlikely to be perfect ever 

FDA-OC_FOl_2020-6423_002317 
2020-06-09 13:50:10 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 09 Jun 2020 09:50:10 -0400 

Right. And every state is going to be different. Seems like almost impossible to track. 

FDA-OC_FOl_2020-6423_002318 
2020-06-09 15:36:49 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 09 Jun 2020 11 :36:49 -0400 

We should be good on CDC guidance now. CDRH is good with language CMS just sent. 

FDA-OC_FOl_2020-6423_002319 
2020-06-09 15:55:17 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Tue, 09 Jun 2020 11 :55: 17 -0400 

Liked "We should be good on CDC guidance now. CDRH is good with language CMS just sent. " 

FDA-OC_FOl_2020-6423_002320 
2020-06-10 17:04:11 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Wed, 10 Jun 2020 13:04:11 -0400 

You can give AMA a heads up on Remdesivir and CQ. Just got the all clear from Patrizia. Likely Friday. 

FDA-OC_FOl_2020-6423_002321 
2020-06-10 17:05:23 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Wed, 10 Jun 2020 13:05:23 -0400 

Patrizia sent us an explanation email. Make sure you tell him it's CCI. 

FDA-OC_FOl_2020-6423_002322 
2020-06-11 14:46:13 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Thu, 11 Jun 2020 10:46:13 -0400 

____ J..am.noJhe . ..c.aU. •. eatrjzia...aop Center are comfortable i (b)(5) : l_ ______________________ ( b) ( 5) ·-·-·-·-·-·-·-·-·-·-·-· i '-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

FDA-OC_FOl_2020-6423_002323 
2020-06-11 14:54:38 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Thu, 11 Jun 2020 10:54:38 -0400 

These Comms calls are super strange. 

FDA-OC_FOl_2020-6423_002324 
2020-06-11 16:23:15 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Thu, 11 Jun 2020 12:23:15 -0400 

It's the same time as the JW plasma call, but to your point earlier you probably don't need to join. 

FDA-OC_FOl_2020-6423_002325 
2020-06-11 16:23:26 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Thu, 11 Jun 2020 12:23:26 -0400 

Liked "It's the same time as the JW plasma call, but to your point earlier you probably don't need to join. " 

FDA-OC_FOl_2020-6423_002326 
2020-06-14 11 :41 :13 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: 

To: 

Date: 

Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Sun, 14 Jun 2020 07:41:13-0400 

I'm sorry to bother you but I'm going to need your help with this 

Peter 

I received the following from Congressman Mccaul this evening. I don't at all want to prejudge the outcome. I think they 

just need clarity. Could you reach out to the company? I'll also arrange a call for the 2 of us with the congressman. 

Thx 

scd.2020.0080.pdf 

Dr. Hahn, Michael Mccaul here, please see the published periodical. I would like to discuss this with you as soon as 

,.onssihlR __ We . ..qeed to move this it's been two weeks and people are dying. We know this is safe and works! Call me at 

L_ ________ (b )(6) ______ __Jhanks! 

l~::::::J~j(~L:::::Jr was·told this is·• "new FDAr !~1~~1reaucratic·one. -i·am ·ci,.ocem,:,g_llvJ!leJa,;_KQL ___ __j ____ uro.encv __ demonstrated.h\l.Y..OuL.siaff .aiven.ibe...tremend.o.usJos.s_of.Jife __ durjoo...tb.is..nandemic,.L. _______________________ .l~)1~L-._·_·_·_·_·_·_·_·_· _ __; 

_j_____________________ ( b) ( 4) i l (b )(4) iThave ~een very-patfenf an~ workeff on ·this· ma~er as-appro_priat~ ·u_nder your-g~idance-but-ln do ·no~ headrom·-·' 

-~:v.01rorvn.ur.staff .10Jhe.nearJu.tur.e..Lw1IJ.have...no.nther.cllo1ce . ..b.ut..to_.raLse_th1s_.1S.sue_.to . ..a.hmherJeY..eL.Ib.e_WH.1s._aware._of i (b)(4) ! 

! ·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·_(b)(4) ________________________________________________ _["Thank you for your attention to this matter and I look forward to · hearing from you in the near future. 

Sincerely, 

Michael Mccaul 

FDA-OC_FOl_2020-6423_002327 
2020-06-14 11 :43:51 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Sun, 14 Jun 2020 07:43:51 -0400 

Do you know the product name? 

FDA-OC_FOl_2020-6423_002328 
2020-06-14 11 :46:12 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Sun, 14 Jun 2020 07:46:12 -0400 

I am sure Colin will remember. Let me touch base with him and Karas and i will get back to you. 

FDA-OC_FOl_2020-6423_002329 
2020-06-14 11 :49:13 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Sun, 14 Jun 2020 07:49:13 -0400 

Thank you 

FDA-OC_FOl_2020-6423_002330 
2020-06-14 11 :49:52 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Sun, 14 Jun 2020 07:49:52 -0400 

FDA-OC_FOl_2020-6423_002331 
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FDA-OC_FOl_2020-6423_002339 
2020-06-14 14:25:22 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Sun, 14 Jun 2020 10:25:22 -0400 

I'll respond 

FDA-OC_FOl_2020-6423_002340 
2020-06-14 14:27:35 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Sun, 14 Jun 2020 10:27:35 -0400 

Thx 

FDA-OC_FOl_2020-6423_002341 
2020-06-14 14:38:40 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Sun, 14 Jun 2020 10:38:40 -0400 

___ Pd~~r:::rofigw .U.P foryou and_ have _learned_ thai-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-iiij(4f "-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-1 ______ , 

! (b)(4) I 

i ·how you. would like to -proceed.·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ( b )( 4) ·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-_J·pfeiase-ief me-know-·-·-·-·-! 

Steve 

FDA-OC_FOl_2020-6423_002342 
2020-06-14 14:38:56 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

Date: Sun, 14 Jun 2020 10:38:56 -0400 

We need tdL----·-·-·-·-·-·-·-· ( b )( 5) -·-·-·-·-·-·-·-·___: 

FDA-OC_FOl_2020-6423_002343 
2020-06-14 14:39:21 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Sun, 14 Jun 2020 10:39:21 -0400 

Yes sir 

FDA-OC_FOl_2020-6423_002344 
2020-06-14 14:45:00 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages J 

From: Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sf"-·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Sun, 14 Jun 2020 10:45:00 -0400 

Ok. Can we chat for 2 mins on EUA? 

FDA-OC_FOl_2020-6423_002345