2020-10-06 14:09:34 UTC: i (b)(G) i Messages-> 

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

From: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Tue, 06 Oct 2020 10:09:34 -0400 

Colin sharing a few tweets on vaccine meeting materials and landing page for your review. Just wanted to make sure you 

are on the lookout and considering. 

FDA-OC _FOl_2020-6423_00054 7 
2020-10-06 14:10:04 UTC: i (b)(G) i Messages-> 

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

From: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Tue, 06 Oct 2020 10:10:04 -0400 

feel free to call if you want to talk thru 

FDA-OC_FOl_2020-6423_000548 
2020-10-06 21 :00:01 UTC: i (b)(G) i Messages -> 

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

From: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Tue, 06 Oct 2020 17:00:01 -0400 

Hi sir, we had a few live radio hits and a taped tv interview via zoom for tomorrow AM. Wanted to check with you on 

whether you'd like to proceed. 

FDA-OC_FOl_2020-6423_000549 
2020-10-06 21 :05:06 UTC: i (b)(G) i Messages -> 

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

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

To: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 06 Oct 2020 17:05:06 -0400 

What is your recommendation? 

FDA-OC_FOl_2020-6423_000550 
2020-10-06 21 :14:16 UTC: i (b)(G) i Messages-> 

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

From: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Tue, 06 Oct 2020 17:14:16 -0400 

FYI - TV one you can do from home via zoom but I'm confirming with ASPA that we are clear to proceed 

FDA-OC_FOl_2020-6423_000551 
2020-10-06 21 :15:03 UTC: i (b)(G) i Messages-> 

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

From: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Tue, 06 Oct 2020 17:15:03 -0400 

; _____ i;m_gJ!J~D-.W~-G~fl __ m.~K~.rn_9-Q.IT!D1~.m:t~ti.gn. If you're comfortabl~ { b) { 5) i 

l __________________ (b)(S) _________________ : •------------------------------------------------------------~ 

FDA-OC_FOl_2020-6423_000552 
2020-10-06 21 :18:28 UTC: i (b)(G) i Messages-> 

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

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

To: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 06 Oct 2020 17:18:28 -0400 

! __________________________________________________________ ___( b )_ ( 5) ·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·_] 

FDA-OC_FOl_2020-6423_000553 
2020-10-06 21 :19:29 UTC: i (b)(G) i Messages-> 

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

From: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Tue, 06 Oct 2020 17:19:29 -0400 

1·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-, 

Ok, not sure how we can get around it, other than try to pivot. If not comfortable) ( b) ( 5) !1 but WH wants us to 

do embers hits •-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·; 

FDA-OC_FOl_2020-6423_000554 
2020-10-06 21 :21 :00 UTC: i (b)(G) i Messages -> 

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

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

To: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 06 Oct 2020 17:21 :00 -0400 

What are the recommendations of the WH on how to handle those questions? 

FDA-OC_FOl_2020-6423_000555 
2020-10-06 21 :38:20 UTC: i (b)(G) i Messages-> 

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

From: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Tue, 06 Oct 2020 17:38:20 -0400 

They gaye __ u_s.._s_Qm.eJp_oJi_ne.s._butL.dP.n'.tthJo_k_tb.e.Y...aJe __ g_Qod_.a.nd . .w.e._.a.reJi.keJ.y to get asked specifically about regeneron. I 

WO u Id i·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ( b )( 5) -·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· i 

FDA-OC_FOl_2020-6423_000556 
2020-10-06 21 :59:24 UTC: i (b)(G) i Messages-> 

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

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

To: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 06 Oct 2020 17:59:24 -0400 

Ok 

FDA-OC_FOl_2020-6423_000557 
2020-10-06 22:00:10 UTC: i (b)(G) i Messages-> 

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

From: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Tue, 06 Oct 2020 18:00: 1 O -0400 

Do you have a moment to chat through? 

FDA-OC_FOl_2020-6423_000558 
2020-10-07 00:39:34 UTC: i (b)(G) i Messages-> 

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

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

To: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 06 Oct 2020 20:39:34 -0400 

Whata€TMs the schedule tomorrow morning? 

FDA-OC_FOl_2020-6423_000559 
2020-10-07 00:40:13 UTC: i (b)(G) i Messages-> 

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

From: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Tue, 06 Oct 2020 20:40: 13 -0400 

• 7:35-7:45 a.m. - "RJ Harris Breakfast Show" on WHP AM580 in Harrisburg, PA (radio, live, host) 

• 8:15-8:23 a.m. - "The Ross Kaminsky Show" on KHOW in Denver, CO (radio, live, host) 

FDA-OC_FOl_2020-6423_000560 
2020-10-07 00:41 :22 UTC: i (b)(G) i Messages-> 

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

From: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Tue, 06 Oct 2020 20:41 :22 -0400 

Jane will text you ahead of them to talk through anything you'd like. And she is going to make sure she has contacts so 

she can help get you off the air if they go long. 

FDA-OC_FOl_2020-6423_000561 
2020-10-07 00:41 :59 UTC: i (b)(G) i Messages-> 

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

From: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Tue, 06 Oct 2020 20:41 :59 -0400 

We sent through some pivot points and talkers to Jakea. you may have those already or should receive shortly 

FDA-OC_FOl_2020-6423_000562 
2020-10-07 00:42:23 UTC: i (b)(G) i Messages-> 

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

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

To: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 06 Oct 2020 20:42:23 -0400 

Liked "Jane will text you ahead of them to talk through anything you'd like. And she is going to make sure she has 

contacts so she can help get you off the air if they go long." 

FDA-OC_FOl_2020-6423_000563 
2020-10-07 00:42:29 UTC: i (b)(G) i Messages-> 

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

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

To: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 06 Oct 2020 20:42:29 -0400 

Thx 

FDA-OC_FOl_2020-6423_000564 
2020-10-07 00:42:51 UTC: i (b)(G) i Messages-> 

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

From: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Tue, 06 Oct 2020 20:42:51 -0400 

You're welcome. Please let me know if you need anything or run into any problems. 

FDA-OC_FOl_2020-6423_000565 
2020-10-14 11 :44:30 UTC: i (b)(G) i Messages-> 

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

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

To: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Wed, 14 Oct 2020 07:44:30 -0400 

Do you who is staffing my 8 am interview! 

FDA-OC_FOl_2020-6423_000566 
2020-10-14 11 :44:49 UTC: i (b)(G) i Messages-> 

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

From: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Wed, 14 Oct 2020 07:44:49 -0400 

Yes, Stephanie and one of our press officers 

FDA-OC_FOl_2020-6423_000567 
2020-10-14 11 :45:30 UTC: i (b)(G) i Messages-> 

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

From: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Wed, 14 Oct 2020 07:45:30 -0400 

do you want to me to ask Stephanie to call you? 

FDA-OC_FOl_2020-6423_000568 
2020-10-14 11 :50:39 UTC: i (b)(G) i Messages-> 

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

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

To: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Wed, 14 Oct 2020 07:50:39 -0400 

Please 

FDA-OC_FOl_2020-6423_000569 
2020-10-14 12:12:33 UTC: i (b)(G) i Messages-> 

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

From: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Wed, 14 Oct 2020 08:12:33 -0400 

FYI - We are still working with CDER and ORA on response on Reuters story on Lilly inspection. if drew asks, just tell him 

your team can follow up with him on it. 

FDA-OC_FOl_2020-6423_000570 
2020-11-21 19:48:17 UTC: i (b)(G) i Messages-> 

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

From: 

To: 

Date: 

Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Sat, 21 Nov 2020 14:48:17 -0500 

Happy Saturday, Dr. Hahn! CDER made a few edits to your quote in the regeneron release. Does this work for you? 

"The FDA remains committed to advancing the nation's public health during this unprecedented pandemic. Authorizing 

these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our health 

care system," said FDA Commissioner Stephen M. Hahn, M.D. "As part of our Coronavirus Treatment Acceleration 

Program, the FDA uses every possible pathway to make new treatments available to patients as quickly as possible while 

continuing to study the safety and effectiveness of these treatments." 

FDA-OC_FOl_2020-6423_000571 
2020-11-21 19:55:53 UTC: i (b)(G) i Messages -> 

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

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

To: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Sat, 21 Nov 2020 14:55:53 -0500 

Approved 

FDA-OC_FOl_2020-6423_000572 
2020-11-21 19:59:16 UTC: i (b)(G) i Messages-> 

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

From: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Sat, 21 Nov 2020 14:59:16 -0500 

Thank you. FYI - sounds like we are still on track for CDER to take action this afternoon/evening. Have a good weekend. 

FDA-OC_FOl_2020-6423_000573 
2020-11-21 20:02:35 UTC: i (b)(G) i Messages -> 

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

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

To: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Sat, 21 Nov 2020 15:02:35 -0500 

Excellent 

FDA-OC _FOl_2020-6423_00057 4 
2020-11-22 00:11 :46 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages 1 

From: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Sat, 21 Nov 2020 19: 11 :46 -0500 

Regen action happened, documents and PR going now 

FDA-OC_FOl_2020-6423_000575 
2020-11-22 00:48:45 UTC: i (b)(G) i Messages-> 

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

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

To: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Sat, 21 Nov 2020 19:48:45 -0500 

Thx 

FDA-OC_FOl_2020-6423_000576 
2020-11-22 18:17:29 UTC: i (b)(G) i Messages-> 

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

From: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Sun, 22 Nov 2020 13:17:29-0500 

Good afternoon. Sent you a few proposed tweets that we'd like to put out today. 

FDA-OC_FOl_2020-6423_000577 
2020-11-23 00:28:38 UTC: i (b)(G) i Messages-> 

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

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

To: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Sun, 22 Nov 2020 19:28:38 -0500 

Interview? 

FDA-OC_FOl_2020-6423_000578 
2020-11-23 00:29:04 UTC: i (b)(G) i Messages-> 

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

From: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Sun, 22 Nov 2020 19:29:04 -0500 

Yes, ita€TMs an interview for a podcast re: vaccines 

FDA-OC_FOl_2020-6423_000579 
2020-11-23 00:29:40 UTC: i (b)(G) i Messages-> 

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

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

To: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Sun, 22 Nov 2020 19:29:40 -0500 

Ok great 

FDA-OC_FOl_2020-6423_000580 
2020-11-23 00:30:10 UTC: i (b)(G) i Messages-> 

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

From: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Sun, 22 Nov 2020 19:30:10 -0500 

It's for MedPage Today, so a more healthcare professional audience 

FDA-OC_FOl_2020-6423_000581 
2020-12-04 22:39:53 UTC: i (b)(G) i Messages-> 

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

From: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Fri, 04 Dec 2020 17:39:53 -0500 

Hi sir - flagging the at home test press release I emailed earlier for your review. Thanks! 

FDA-OC_FOl_2020-6423_000582 
2020-12-04 22:49:36 UTC: i (b)(G) i Messages-> 

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

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

To: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Fri, 04 Dec 2020 17:49:36 -0500 

Approved 

Thx 

FDA-OC_FOl_2020-6423_000583 
2020-12-04 22:51 :02 UTC: i (b)(G) i Messages-> 

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

From: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Fri, 04 Dec 2020 17:51 :02 -0500 

Liked "Approved 

Thx" 

FDA-OC_FOl_2020-6423_000584 
2020-12-09 21 :26:18 UTC: i (b)(G) i Messages-> 

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

From: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Wed, 09 Dec 2020 16:26:18-0500 

Hi sir, flagging that I sent through the vaccine statement for your review a€" we are aiming to issue tomorrow morning. 

FDA-OC_FOl_2020-6423_000585 
2020-12-09 21 :29:22 UTC: i (b)(G) i Messages -> 

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

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

To: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Wed, 09 Dec 2020 16:29:22 -0500 

Approved 

FDA-OC_FOl_2020-6423_000586 
2020-12-09 21 :29:31 UTC: i (b)(G) i Messages-> 

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

From: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Wed, 09 Dec 2020 16:29:31 -0500 

Liked "Approved " 

FDA-OC_FOl_2020-6423_000587 
2020-12-09 21 :29:35 UTC: i (b)(G) i Messages-> 

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

From: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Wed, 09 Dec 2020 16:29:35 -0500 

Thank you! 

FDA-OC_FOl_2020-6423_000588 
2020-12-14 00:43:54 UTC: i (b)(G) i Messages-> 

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

From: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Sun, 13 Dec 2020 19:43:54 -0500 

Took longer than I would've liked but Politico updated the story to clarify allergy language re: components of the specific 

vaccine 

FDA-OC_FOl_2020-6423_000589 
2020-12-14 00:44:42 UTC: i (b)(G) i Messages-> 

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

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

To: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Sun, 13 Dec 2020 19:44:42 -0500 

Thank you 

Why did they balk? 

FDA-OC_FOl_2020-6423_000590 
2020-12-14 00:45:38 UTC: i (b)(G) i Messages-> 

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

From: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Sun, 13 Dec 2020 19:45:38 -0500 

They didn't balk. The reporter who wrote it must have not been checking their email so I had to track down someone else 

who could help correct the story. 

FDA-OC_FOl_2020-6423_000591 
2020-12-14 01 :00:57 UTC: i (b)(G) i Messages-> 

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

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

To: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Sun, 13 Dec 2020 20:00:57 -0500 

Oh ok 

FDA-OC_FOl_2020-6423_000592 
2020-10-02 11 :07:21 UTC: i (b)(G) i Messages -> 

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

From: Adam Schechter C~~~~~~~~~~i~ii~L~~~~~~~~~~]@native messages"> 

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

Date: Fri, 02 Oct 2020 07:07:21 -0400 

If you need anything from us please let me know. Stay safe 

FDA-OC_FOl_2020-6423_000593 
2020-10-02 11 :44:04 UTC: i (b)(G) i Messages -> 

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

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

To: Adam Schechter :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Fri, 02 Oct 2020 07:44:04 -0400 

ThxAdam 

FDA-OC_FOl_2020-6423_000594 
2020-10-02 21 :52:10 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages 1 ' 

From: Dana Bash :·-·-·-·-·-·-·-·-·-·-·(ii)ist-·-·-·-·-·-·-·-·-·-·: messages"> 

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

Date: Fri, 02 Oct 2020 17:52:10 -0400 

This is disturbing 

FDA-OC_FOl_2020-6423_000595 
2020-10-03 00:35:40 UTC: i (b)(G) i Messages-> 

!._ _______________________________ ( b )( 6) _____________________________ ___! Mess ages] 

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

To: Dana Bash :·-·-·-·-·-·-·-·-·-·-·(ii)ist-·-·-·-·-·-·-·-·-·-·: messages"> 

Date: Fri, 02 Oct 2020 20:35:40 -0400 

The entire situation? 

FDA-OC_FOl_2020-6423_000596 
2020-10-03 00:38:09 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages 1 ' 

From: Dana Bash :·-·-·-·-·-·-·-·-·-·-·(ii)ist-·-·-·-·-·-·-·-·-·-·: messages"> 

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

Date: Fri, 02 Oct 2020 20:38:09 -0400 

Well yes. Seems that the president is in bad shape to allow himself to go to Walter Reed 

FDA-OC_FOl_2020-6423_000597 
2020-10-06 11 :11 :12 UTC: i (b)(G) i Messages-> 

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

From: Dana Bash :·-·-·-·-·-·-·-·-·-·-·(ii)ist-·-·-·-·-·-·-·-·-·-·: messages"> 

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

Date: Tue, 06 Oct 2020 07: 11: 12 -0400 

Good morning 

I'm on soon talking about the Nyt story 

Let me know if there is anything I should know 

FDA-OC_FOl_2020-6423_000598 
2020-12-01 16:06:27 UTC: i (b)(G) i Messages -> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages 1 ' 

From: Dana Bash :·-·-·-·-·-·-·-·-·-·-·(ii)ist-·-·-·-·-·-·-·-·-·-·: messages"> 

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

Date: Tue, 01 Dec 2020 11 :06:27 -0500 

Hi. Anchoring at noon (one hour) 

I want To make sure I capture this meeting right 

Call if you have 2 seconds. 

Or text. 

Thx 

FDA-OC_FOl_2020-6423_000599 
2020-10-05 21 :06:47 UTC: i (b)(G) i Messages-> 

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

From: Leonard S. Schleifer [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: George Yancopoulos [:::::::::j~i(sf::::::::J messages">, Stephen Hahn [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J 

messages"> 

Date: Mon, 05 Oct 2020 17:06:47 -0400 

Steve, I heard call went well but it would be great for you, George, and me get together for a brief debrief. Can we call u 

at 6? 

FDA-OC_FOl_2020-6423_000600 
2020-10-05 21 :07:14 UTC: i (b)(G) i Messages-> 

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

From: Leonard S. Schleifer [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: George Yancopoulos [:::::::::j~i(sf::::::::J messages">, Stephen Hahn [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J 

messages"> 

Date: Mon, 05 Oct 2020 17:07:14 -0400 

if u would like to send us a dial in and have a colleague join that would be fine 

FDA-OC_FOl_2020-6423_000601 
2020-10-05 21 :08:43 UTC: i (b)(G) i Messages-> 

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

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

To: George Yancopoulos [:::::::::j~i(sf::::::::J messages">, Leonard S. Schleifer [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J 

messages"> 

Date: Mon, 05 Oct 2020 17:08:43 -0400 

[ _________________________________________________ (_b) (_6) ·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·----'Can we talk tomorrow 

FDA-OC_FOl_2020-6423_000602 
2020-10-05 21 :09:17 UTC: i (b)(G) i Messages-> 

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

From: Leonard S. Schleifer [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: George Yancopoulos [:::::::::j~i(sf::::::::J messages">, Stephen Hahn [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J 

messages"> 

Date: Mon, 05 Oct 2020 17:09:17 -0400 

Yes. Please propose time and dial in. We will accommodate 

FDA-OC_FOl_2020-6423_000603 
2020-10-05 21 :46:05 UTC: i (b)(G) i Messages-> 

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

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

To: George Yancopoulos [:::::::::j~i(sf::::::::J messages">, Leonard S. Schleifer [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J 

messages"> 

Date: Mon, 05 Oct 2020 17:46:05 -0400 

Will do 

FDA-OC_FOl_2020-6423_000604 
2020-10-07 12:15:25 UTC: i (b)(G) i Messages-> 

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

From: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Wed, 07 Oct 2020 08:15:25 -0400 

FDA-OC_FOl_2020-6423_000605 
2020-10-07 12:29:52 UTC: i (b)(G) i Messages-> 

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

From: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Wed, 07 Oct 2020 08:29:52 -0400 

Nicely done. 

FDA-OC_FOl_2020-6423_000606 
2020-10-07 12:36:05 UTC: i (b)(G) i Messages -> 

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

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

To: Jane Hubbard [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Michael Felderbaum [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J 

messages"> 

Date: Wed, 07 Oct 2020 08:36:05 -0400 

Thx. I'll need to clean up the response to the 2 month question 

FDA-OC_FOl_2020-6423_000607 
2020-10-07 12:37:32 UTC: i (b)(G) i Messages-> 

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

From: Michael Felderbaum [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Wed, 07 Oct 2020 08:37:32 -0400 

Would you like us to get a few more talkers on that from CBER? 

FDA-OC_FOl_2020-6423_000608 
2020-10-07 12:44:21 UTC: i (b)(G) i Messages -> 

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

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

To: Jane Hubbard [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Michael Felderbaum [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J 

messages"> 

Date: Wed, 07 Oct 2020 08:44:21 -0400 

Yes I spoke to SC 

FDA-OC_FOl_2020-6423_000609 
2020-10-07 12:44:39 UTC: i (b)(G) i Messages-> 

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

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

To: Jane Hubbard [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Michael Felderbaum [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J 

messages"> 

Date: Wed, 07 Oct 2020 08:44:39 -0400 

Thank you 

FDA-OC_FOl_2020-6423_000610 
2020-10-07 12:47:16 UTC: i (b)(G) i Messages-> 

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

From: Jane Hubbard :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Michael Felderbaum [:::::::::j~i(sf::::::::J messages">, Stephen Hahn [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Wed, 07 Oct 2020 08:47:16 -0400 

SC and I spoke and we will get you something top line on the 2-month follow up. 

FDA-OC_FOl_2020-6423_000611 
2020-10-07 12:51 :01 UTC: i (b)(G) i Messages -> 

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

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

To: Jane Hubbard [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Michael Felderbaum [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J 

messages"> 

Date: Wed, 07 Oct 2020 08:51 :01 -0400 

Thx 

FDA-OC_FOl_2020-6423_000612 
2020-10-07 21 :30:41 UTC: i (b)(G) i Messages -> 

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

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

To: Jared Kushner :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·1 messages"> 

Date: Wed, 07 Oct 2020 17:30:41 -0400 

Could you take a call today or tomorrow? 

FDA-OC_FOl_2020-6423_000613 
2020-10-07 21 :32:20 UTC: i (b)(G) i Messages-> 

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

From: Jared Kushner :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

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

Date: Wed, 07 Oct 2020 17:32:20 -0400 

Yes. Call any time 

FDA-OC_FOl_2020-6423_000614 
2020-10-11 17:17:48 UTC: i (b)(G) i Messages-> 

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

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

To: Jared Kushner :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·1 messages"> 

Date: Sun, 11 Oct 2020 13:17:48 -0400 

Can you take a quick call? 

FDA-OC_FOl_2020-6423_000615 
2020-10-11 20:09:02 UTC: i (b)(G) i Messages-> 

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

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

To: Jared Kushner :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·1 messages"> 

Date: Sun, 11 Oct 2020 16:09:02 -0400 

Call went very well 

FDA-OC_FOl_2020-6423_000616 
2020-10-11 20:09:26 UTC: i (b)(G) i Messages-> 

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

From: Jared Kushner :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

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

Date: Sun, 11 Oct 2020 16:09:26 -0400 

FDA-OC_FOl_2020-6423_000617 
2020-10-08 00:57:26 UTC: i (b)(G) i Messages-> 

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

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

To: Katie Miller :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·1 messages"> 

Date: Wed, 07 Oct 2020 20:57:26 -0400 

https://www.sciencemag.org/news/2020/1 0/heres-what-known-about-president-donald-trump-s-covid-19-treatment 

FDA-OC_FOl_2020-6423_000618 
2020-10-08 00:57:45 UTC: i (b)(G) i Messages-> 

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

From: 

To: 

Date: 

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

Katie Miller :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·1 messages"> 

Wed, 07 Oct 2020 20:57:45 -0400 

Did Regeneron use aborted fetal cells to make the monoclonal antibodies that Trump received? 

No. Although the monoclonal antibodies infused into Trump were not made from or in fetal cells, Regeneron did develop 

that treatment with the help of a long-lived line of cells established from the kidneys of a fetus electively aborted in the 

Netherlands around 1972. The company relied on those widely used cells, known HEK-293 cells, to make mimics of the 

coronavirus spike protein. Researchers used these proteins to test the potency of antibodies found in COVID-19 patients 

or made in mice with a humanlike immune system (see initial question}. The antibodies selected for the company's 

cocktail, however, were then mass produced in nonfatal cells. The creation of the humanized mice also did not rely on 

HEK-293 cells or other cells from aborted fetuses or human embryos. Regeneron scientists detail their methods in the 

supplementary material to this paper published in Science in August. 

FDA-OC_FOl_2020-6423_000619 
2020-10-08 00:58:12 UTC: i (b)(G) i Messages-> 

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

From: Katie Miller :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

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

Date: Wed, 07 Oct 2020 20:58:12 -0400 

Thank u sir 

FDA-OC_FOl_2020-6423_000620 
2020-11-13 21 :42:17 UTC: i (b)(G) i Messages-> 

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

From: Katie Miller :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

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

Date: Fri, 13 Nov 2020 16:42:17 -0500 

[::::::::::::::::::::::::::::::::::::::::::::::::::: ( b) ( 6) ::::::::::::::::::::::::::::::::::::::::::::::::::::: i 

FDA-OC_FOl_2020-6423_000621 
2020-12-21 23:49:10 UTC: i (b)(G) i Messages-> 

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

From: Katie Miller :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

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

Date: Mon, 21 Dec 2020 18:49:10 -0500 

Call me back. Fro some reason when I call you. It goes straight to voicemail 

FDA-OC_FOl_2020-6423_000622 
2020-12-22 01 :37:06 UTC: i (b)(G) i Messages-> 

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

From: Katie Miller :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

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

Date: Mon, 21 Dec 2020 20:37:06 -0500 

Just tried you back 

FDA-OC_FOl_2020-6423_000623 
2020-10-17 18:35:12 UTC: i (b)(G) i Messages-> 

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

From: [·-·-·-·-·-·-·-·-·-·~(iiWlf·-·-·-·-·-·-·-·-·-·1 messages" 

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

Date: Sat, 17 Oct 2020 14:35:12 -0400 

Long time. Hope all is well. Good luck with the vaccines. Approval of remdesivir will be dicey given SOLIDARITY, I think. 

But I'm not the head of the FDA thank goodness _ 

FDA-OC_FOl_2020-6423_000624 
2020-10-17 18:36:29 UTC: i (b)(G) i Messages -> 

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

From: [·-·-·-·-·-·-·-·-·-·~(iiWlf·-·-·-·-·-·-·-·-·-·1 messages" 

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

Date: Sat, 17 Oct 2020 14:36:29 -0400 

Do you think Tony or someone else can get out there and discuss the importance of trans-infection of SARS-CoV-2 in its 

pathogenesis. Tony discovered for HIV after all. 

FDA-OC_FOl_2020-6423_000625 
2020-10-17 18:36:40 UTC: i (b)(G) i Messages -> 

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

From: [·-·-·-·-·-·-·-·-·-·~(iiWlf·-·-·-·-·-·-·-·-·-·1 messages" 

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

Date: Sat, 17 Oct 2020 14:36:40 -0400 

Hope all is well. 

FDA-OC_FOl_2020-6423_000626 
2020-10-22 19:34:48 UTC: i (b)(G) i Messages-> 

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

From: David Gortler C~~~~~~~~~~i~ii~L~~~~~~~~~~]@native messages"> 

To: Keagan Lenihan [:::::::::j~i(sf::::::::J messages">, Stephen Hahn [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Thu, 22 Oct 2020 15:34:48 -0400 

Someone just forwarded that repellent and deeply biased politico article, filled with conjecture and outrageous 

unsubstantiated claims. 

I just want you to know that I believe you're a very intelligent and honorable person and believe that you are doing the 

right things with regards to safety. 

FDA-OC_FOl_2020-6423_000627 
2020-11-23 17:49:24 UTC: i (b)(G) i Messages -> 

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

From: Andrew Tantillo [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Mon, 23 Nov 2020 12:49:24 -0500 

That went very well. Don't think you need to change anything, but please let me know if you want any other TPs or info for 

next calls. 

FDA-OC_FOl_2020-6423_000628 
2020-12-12 02:46:07 UTC: i (b)(G) i Messages-> 

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

From: Andrew Tantillo [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Fri, 11 Dec 2020 21 :46:07 -0500 

So proud to be with FDA tonight. Thank you. 

FDA-OC_FOl_2020-6423_000629 
2020-12-12 11 :56:55 UTC: i (b)(G) i Messages-> 

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

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

To: Andrew Tantillo [·-·-·-·-·-·-·-·-·-·-jii)(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Sat, 12 Dec 2020 06:56:55 -0500 

Thanks Andy. Heroic work by our teams 

FDA-OC_FOl_2020-6423_000630 
2020-12-19 14:28:22 UTC: i (b)(G) i Messages-> 

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

From: Andrew Tantillo [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Sat, 19 Dec 2020 09:28:22 -0500 

Know what - do t change your statement at last minute to accommodate my idea. I should have included it. I can make 

that point w staff after. 

FDA-OC_FOl_2020-6423_000631 
2020-12-19 14:28:36 UTC: i (b)(G) i Messages-> 

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

From: Andrew Tantillo [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Sat, 19 Dec 2020 09:28:36 -0500 

*don't 

FDA-OC_FOl_2020-6423_000632 
2020-12-19 14:28:47 UTC: i (b)(G) i Messages-> 

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

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

To: Andrew Tantillo [·-·-·-·-·-·-·-·-·-·-jii)(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Sat, 19 Dec 2020 09:28:47 -0500 

Ok 

FDA-OC_FOl_2020-6423_000633 
2020-12-19 14:29:00 UTC: i (b)(G) i Messages-> 

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

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

To: Andrew Tantillo [·-·-·-·-·-·-·-·-·-·-jii)(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Sat, 19 Dec 2020 09:29:00 -0500 

I should be able to do it 

FDA-OC_FOl_2020-6423_000634 
2020-10-27 01 :40:37 UTC: i (b)(G) i Messages-> 

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

From: [·-·-·-·-·-·-·-·-·-·~(iiWlf·-·-·-·-·-·-·-·-·-·1 messages" 

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

Date: Mon, 26 Oct 2020 21 :40:37 -0400 

FYI. 

FDA-OC_FOl_2020-6423_000635 
2020-10-27 01 :40:37 UTC: i (b)(G) i Messages-> 

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

From: [·-·-·-·-·-·-·-·-·-·~(iiWlf·-·-·-·-·-·-·-·-·-·1 messages" 

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

Date: Mon, 26 Oct 2020 21 :40:37 -0400 

https://www.sciencedirect.com/science/article/pii/S0924857920304258 

FDA-OC_FOl_2020-6423_000636 
2020-12-20 18:03:21 UTC: i (b)(G) i Messages -> 

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

From: [·-·-·-·-·-·-·-·-·-·~(iiWlf·-·-·-·-·-·-·-·-·-·1 messages" 

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

Date: Sun, 20 Dec 2020 13:03:21 -0500 

https://twitter.com/zev _ dr/status/134071527 4140606466?s=21 

FDA-OC_FOl_2020-6423_000637 
Non-Responsive Document. 

FDA-OC_FOl_2020-6423_000638 
2020-10-28 23:31 :55 UTC: i (b)(G) i Messages-> 

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

From: Francis Collins :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

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

Date: Wed, 28 Oct 2020 19:31:55 -0400 

Hi Steve, 

I checked with Cliff Lane of NIAID. ACTIV-3 DSMB report went to CDER yesterday. See note below from Cliff. 

Francis 

Closed DSMB report sent by email at 3:01 PM yesterday (Tuesday) to Alicia Moruf and John Farley of CDER. Officially 

submitted to our IND today. John is Director of the Office of Infectious Diseases. He reports to the Director of the Office 

of New Drugs who reports to Patrizia. 

FDA-OC_FOl_2020-6423_000639 
2020-10-28 23:41 :17 UTC: i (b)(G) i Messages-> 

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

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

To: Francis Collins :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·1 messages"> 

Date: Wed, 28 Oct 2020 19:41 :17 -0400 

Thank you 

FDA-OC_FOl_2020-6423_000640 
2020-11-14 19:08:46 UTC: i (b)(G) i Messages-> 

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

From: Francis Collins :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

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

Date: Sat, 14 Nov 2020 14:08:46 -0500 

I spoke to Dolsten. Got time for a quick call with the Secretary and me? Anytime before 5:30 works for me. 

FDA-OC_FOl_2020-6423_000641 
2020-11-04 14:10:06 UTC:i (b)(6) @icloud.com -> '-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·. a ,i·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·r·-•·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·. 

i (b)(G) : 1v1essages, i (b)(G) : 

L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- •-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-

From: i (b)(6) @icloud.com 

To: ' Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages">, Stephen Hahn C.~-~-~-~-~-~-1ilj~L~-~-~-~-~-~1 

Date: Wed, 04 Nov 2020 09:10:06 -0500 

https ://thetexan. news/north-texas-doctor-recovers-from-covid-19-usi ng-hyd roxych loroqu i ne/ 

FDA-OC_FOl_2020-6423_000642 
FDA-OC_FOl_2020-6423_000643 
FDA-OC_FOl_2020-6423_000644 
FDA-OC_FOl_2020-6423_000645 
2020-11-04 14:10:06 UTC: [ {b){6) @icloud.com -> 

l---------------------------------(t>)(sj"-----------------------------·-·1 M e-ssag·i:u;;·T-'·-·-·-·-·-·-·-·(ii.jiGY°-·-·-·-·-·-·-·-·1 

From: [ (b)(6) i@icloud.com 

To: "-·-s1e-·rner-f"Hahn r·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·7 messa es"> Ste hen Hahn !-·-·-·-·-·-·-·ii,ffsY-·-·-·-·-·-·-1 p '·-·-·-·-·-·-·-·-·-·-_(b)(6) _____________________ , g , p '-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

Date: Wed, 04 Nov 2020 09:10:06 -0500 

Haven't bugged you in a while. Thought you might define this article interesting. It seems we've put most (all) of our 

emphasis on late stage therapeutics and vaccines. Have we done any significant work on early treatment? As you know, 

I get a lot of information from advocates of HCQ and other early treatment options. Seems like evidence is growing that 

some of these are showing results around the world. 

FDA-OC_FOl_2020-6423_000646 
2020-11-05 21 :29:34 UTC:i (b)(6) @icloud.com -> 

l _______________________________ Jb )( 6 > -----------------------------·-· ! NI essa g es, !__ ________________ ( b )( G > _________________ ! 

From: i (b)(G) :@icloud.com '-·-·-·-·-·-·-·-·-·-·-·-· To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages">, Stephen Hahn C.~-~-~-~-~-~-1ilj~L~-~-~-~-~-~1 

Date: Thu, 05 Nov 2020 16:29:34 -0500 

I'm available now. Call if you are 

FDA-OC _FOl_2020-6423_00064 7 
2020-11-06 17:27:49 UTC! (b)(6) ~icloud.com -> '-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·. a 111-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·r·-·-··-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·. 

i (b)(G) : 1v1essages, i (b)(G) : 

L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- •-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-

From: i (b)(6) !@icloud.com 

To: L Stephen Hahn r·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·1 messages">, Stephen Hahn c.~-~-~-~-~-~-1ilj~L~-~-~-~-~-~1 

Date: Fri, 06 Nov 2020 12:27:49 -0500 

BTW, You Tube has taken down Dr McCullough's videos. Can't let people hear about early treatments that just might 

work. I guess it's better to let people get really sick so they have to overcrowd our hospitals. _ 

FDA-OC_FOl_2020-6423_000648 
2020-11-09 18:21 :20 UTC: ! (b )(6) @icloud.com -> 

l---------------------------------(b)(sf-----------------------------·-·1 M'e·ssasie-s~-·1·-·"·-·-·-·-·-·-·-·(b.jiiiY--·-·-·-·-·-·-·-·1 

From: [ ____ (b)(6) _____ @icloud.com 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages">, Stephen Hahn C.~-~-~-~-~-~-1ilj~L~-~-~-~-~-~1 

Date: Mon, 09 Nov 2020 13:21:20-0500 

My staff heard that FDA might be preparing an approval on early COVID treatment. If true, it would helpful to know what 

to expect. We are in the process of designing and scheduling a hearing on that exact subject. 

FDA-OC_FOl_2020-6423_000649 
2020-12-09 16:32:06 UTC:i (b)(6) i@icloud.com -> ·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·• L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·"""',!_·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·,. i (b)(G) ! Messages, i (b)(G) ! 

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From: i (b)(G) 1@icloud.com ··-·-·-·-·-·-·-·-·-·-·-·-·~ To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages">, Stephen Hahn C.~-~-~-~-~-~-1ilj~L~-~-~-~-~-~1 

Date: Wed, 09 Dec 2020 11 :32:06 -0500 

FYI: Fox News has posted Dr. Kory's testimony on early treatment with lvermectin on YouTube and it's already gotten 

more than 750,000 views: 

https://www.youtube.com/watch?v=Tq8SX0By-4w&feature=youtu.be 

People want an early treatment option. 

FDA-OC_FOl_2020-6423_000650 
2020-11-11 21 :13:23 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages 1 

From: Jon LaPook CBS :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

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

Date: Wed, 11 Nov 2020 16:13:23 -0500 

Hi StevJ ____________ (b )(6) _____________ i I know you are beyond busy, but if you have literally 60 seconds for a quick question for 

tonight's Evening News, that would be great. If not, I understand. In any case, let's try to chat soon (it can be totally off the 

record!). 

FDA-OC_FOl_2020-6423_000651 
2020-11-11 23:52:21 UTC: i (b)(G) i Messages-> 

l _______________________________ __(_b )( 6 >---·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ! Messages 1 

From: Jon LaPook CBS :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

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

Date: Wed, 11 Nov 2020 18:52:21 -0500 

Steve, may I report that you found out about the Pfizer data at 6:51A on Monday? 

FDA-OC_FOl_2020-6423_000652 
2020-11-12 01 :48:07 UTC: i (b)(G) i Messages -> 

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

From: Jon LaPook CBS :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

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

Date: Wed, 11 Nov 2020 20:48:07 -0500 

Steve, may I report that you found out about the Pfizer data at 6:51A on Monday? 

FDA-OC_FOl_2020-6423_000653 
2020-11-19 14:07:33 UTC: i (b)(G) i Messages-> 

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

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

To: Tim Scott [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Thu, 19 Nov 2020 09:07:33-0500 

Hi Senator. I hope you are well. I'm happy to do another lnstagram session with you re: vaccines if you think that would 

be helpful 

FDA-OC_FOl_2020-6423_000654 
2020-11-19 14:53:32 UTC: i (b)(G) i Messages-> 

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

From: Tim Scott [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Thu, 19 Nov 2020 09:53:32 -0500 

I love the idea. I will run it by my Comms shop & work on a date. 

FDA-OC_FOl_2020-6423_000655 
2020-11-19 15:00:49 UTC: i (b)(G) i Messages -> 

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

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

To: Tim Scott [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Thu, 19 Nov 2020 10:00:49 -0500 

Thank you 

FDA-OC_FOl_2020-6423_000656 
2020-11-24 23:55:34 UTC: i (b)(G) i Messages-> 

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

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

To: Tim Scott [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 24 Nov 2020 18:55:34 -0500 

Thank you Senator. Great session from my perspective 

FDA-OC_FOl_2020-6423_000657 
2020-11-24 23:56:49 UTC: i (b)(G) i Messages-> 

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

From: Tim Scott [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Tue, 24 Nov 2020 18:56:49 -0500 

Ours as well. 

FDA-OC_FOl_2020-6423_000658 
2020-11-24 23:57:05 UTC: i (b)(G) i Messages-> 

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

From: Tim Scott [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Tue, 24 Nov 2020 18:57:05 -0500 

You did well. Gaining momentum!! 

FDA-OC_FOl_2020-6423_000659 
2020-12-17 17:50:29 UTC: i (b)(G) i Messages -> 

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

From: Tim Scott [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Thu, 17 Dec 2020 12:50:29-0500 

FDA-OC_FOl_2020-6423_000660 
FDA-OC_FOl_2020-6423_000661 
2020-11-19 16:02:55 UTC: i (b)(G) i Messages -> 

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

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

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

Date: Thu, 19 Nov 2020 11:02:55-0500 

Thanks for the FB live. Sorry about the interruptions. Hopefully it didn't cause too many issues on your end. 

FDA-OC_FOl_2020-6423_000662 
2020-11-19 16:04:03 UTC: i (b)(G) i Messages -> 

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

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

To: John Torres :·-·-·-·-·-·-·-·-·-·-jii}(sY---·-·-·-·-·-·-·-·-·1 messages"> 

Date: Thu, 19 Nov 2020 11:04:03-0500 

No issues at all. Really great to talk to you John 

FDA-OC_FOl_2020-6423_000663 
2020-11-19 16:05:35 UTC: i (b)(G) i Messages -> 

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

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

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

Date: Thu, 19 Nov 2020 11:05:35-0500 

If possible let's pencil in a time for another one at the eau approval time. Let me know if that'd work for you. 

FDA-OC_FOl_2020-6423_000664 
2020-11-19 16:07:00 UTC: i (b)(G) i Messages -> 

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

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

To: John Torres :·-·-·-·-·-·-·-·-·-·-jii}(sY---·-·-·-·-·-·-·-·-·1 messages"> 

Date: Thu, 19 Nov 2020 11:07:00-0500 

Let's do it. Thx 

FDA-OC_FOl_2020-6423_000665 
2020-12-07 15:40:01 UTC: i (b)(G) i Messages -> 

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

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

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

Date: Mon, 07 Dec 2020 10:40:01 -0500 

Steve, do you have time today for a talk on background about the vaccine? I hope all is well otherwise! 

FDA-OC_FOl_2020-6423_000666 
2020-12-12 14:47:40 UTC: i (b)(G) i Messages-> 

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

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

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

Date: Sat, 12 Dec 2020 09:47:40 -0500 

Steve, great press conference. I think that info puts a lot of folks at ease. Thanks 

FDA-OC_FOl_2020-6423_000667 
2020-12-12 16:42:48 UTC: i (b)(G) i Messages-> 

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

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

To: John Torres :·-·-·-·-·-·-·-·-·-·-jii}(sY---·-·-·-·-·-·-·-·-·1 messages"> 

Date: Sat, 12 Dec 2020 11 :42:48 -0500 

Thx John 

Hope you are well 

FDA-OC_FOl_2020-6423_000668 
2020-12-12 20:42:30 UTC: i (b)(G) i Messages-> 

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

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

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

Date: Sat, 12 Dec 2020 15:42:30 -0500 

Doing well. Thanks. I hope you guys are too and that you get some sleep before round 2_ 

FDA-OC_FOl_2020-6423_000669 
2020-12-12 20:45:30 UTC: i (b)(G) i Messages-> 

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

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

To: John Torres :·-·-·-·-·-·-·-·-·-·-jii}(sY---·-·-·-·-·-·-·-·-·1 messages"> 

Date: Sat, 12 Dec 2020 15:45:30 -0500 

Amen. It's like residency 

FDA-OC_FOl_2020-6423_000670 
2020-11-29 16:58:58 UTC: i (b)(G) i Messages -> 

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

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

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

Date: Sun, 29 Nov 2020 11 :58:58 -0500 

John and John, I'm connecting you. Dr. Fleming, I briefed Dr. Redd. Let me know how I can help 

FDA-OC_FOl_2020-6423_000671 
2020-12-01 13:08:51 UTC: i (b)(G) i Messages -> 

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

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

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

Date: Tue, 01 Dec 2020 08:08:51 -0500 

Hi Stephen .. John Roberts here. Can I pis get the statement you gave to Axios regarding today's meeting? 

Thanks ... John 

FDA-OC_FOl_2020-6423_000672 
2020-12-01 16:01 :39 UTC: i (b)(G) i Messages -> 

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

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

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

Date: Tue, 01 Dec 2020 11 :01 :39 -0500 

Hi again ... anything on the briefing that you can share? 

FDA-OC_FOl_2020-6423_000673 
2020-12-01 17:31 :28 UTC: i (b)(G) i Messages -> 

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

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

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

Date: Tue, 01 Dec 2020 12:31 :28 -0500 

Hi Doc ... John Roberts again ... can you chat? WH is saying that you "weren't taken to the woodshed" over the pace of EUA 

approval - but there was a vigorous discussion on the timeline and what could be done to further expedite it. 

FDA-OC _FOl_2020-6423_00067 4 
2020-12-11 19:56:24 UTC: i (b)(G) i Messages-> 

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

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

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

Date: Fri, 11 Dec 2020 14:56:24 -0500 

Hi Dr. Hahn ... John Roberts here. So I'm just trying to square what the White House just told me with what you appear to 

be saying in regard to your conversation with Mark. Can you enlighten me? Thanks very much. Hope you are well. Big 

day today. 

FDA-OC_FOl_2020-6423_000675 
2020-12-02 15:39:05 UTC: i (b)(G) i Messages-> 

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

From: Drew Armstrong :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

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

Date: Wed, 02 Dec 2020 10:39:05 -0500 

Long time no talk! Have been busy getting two big magazine stories out (including everything you ever wanted to know 

about Lysol} 

FDA-OC_FOl_2020-6423_000676 
2020-12-02 15:39:28 UTC: i (b)(G) i Messages-> 

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

From: Drew Armstrong :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

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

Date: Wed, 02 Dec 2020 10:39:28 -0500 

Am guessing you're slammed these days but lmk if you have time to catch up? 

FDA-OC_FOl_2020-6423_000677 
2020-12-02 15:39:42 UTC: i (b)(G) i Messages-> 

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

From: Drew Armstrong :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

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

Date: Wed, 02 Dec 2020 10:39:42 -0500 

Tobacco, vaccines, the future, etc 

FDA-OC_FOl_2020-6423_000678 
2020-12-09 22:48:07 UTC: i (b)(G) i Messages-> 

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

From: Drew Armstrong :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

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

Date: Wed, 09 Dec 2020 17:48:07 -0500 

And I am also hoping to interview you for a business week piece on vaccines - it would run dee 22, presumably after the 

approvals are done 

FDA-OC_FOl_2020-6423_000679 
2020-12-09 22:50:05 UTC: i (b)(G) i Messages-> 

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

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

To: Drew Armstrong :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Wed, 09 Dec 2020 17:50:05 -0500 

Let's do it 

FDA-OC_FOl_2020-6423_000680 
2020-12-23 15:36:43 UTC: i (b)(G) i Messages-> 

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

From: Drew Armstrong :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

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

Date: Wed, 23 Dec 2020 10:36:43 -0500 

FDA-OC_FOl_2020-6423_000681 
FDA-OC_FOl_2020-6423_000682 
2020-12-23 15:37:02 UTC: i (b)(G) i Messages-> 

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

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

To: Drew Armstrong :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Wed, 23 Dec 2020 10:37:02 -0500 

Very very nice. I read it this morning 

FDA-OC_FOl_2020-6423_000683 
2020-12-23 15:37:38 UTC: i (b)(G) i Messages-> 

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

From: Drew Armstrong :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

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

Date: Wed, 23 Dec 2020 10:37:38 -0500 

Thanks again for speaking on it. Not as extensive a quote as I'd like but a good one. Happy holidays to you and your 

family as well!! 

FDA-OC_FOl_2020-6423_000684 
2020-12-03 21 :38:17 UTC: i (b)(G) i Messages-> 

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

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

To: Tony Fauci :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·1 messages"> 

Date: Thu, 03 Dec 2020 16:38:17 -0500 

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-warns-newly-discoveredpotential-drug-interaction-may-reduce 

FDA-OC_FOl_2020-6423_000685 
Non-Responsive Document. 

FDA-OC_FOl_2020-6423_000686 
2020-12-11 15:25:47 UTC: i (b)(G) i Messages-> 

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

From: James Sigg :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

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

Date: Fri, 11 Dec 2020 10:25:47 -0500 

Hi Dr Hahn, this is Jim. My team and I have a somewhat out of the box idea that I wanted run by you on a potential supply 

of covid vaccines for FDA. Not urgent. I know you have a lot going on. Thanks 

FDA-OC_FOl_2020-6423_000687 
2020-12-12 03:41 :28 UTC: i (b)(G) i Messages-> 

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

From: Alex J. Adams [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Fri, 11 Dec 2020 22:41 :28 -0500 

Thank you for your diligence and efforts which resulted in this truly historic accomplishment! 

-Alex Adams (Idaho Governors office) 

FDA-OC_FOl_2020-6423_000688 
2020-12-12 11 :55:03 UTC: i (b)(G) i Messages-> 

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

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

To: Alex J. Adams [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Sat, 12 Dec 2020 06:55:03 -0500 

Our pleasure Alex. I hope you all are hanging in there 

FDA-OC_FOl_2020-6423_000689 
2020-12-12 15: 31 : 31 UTC: cookee@who. int -> r-·-------------------------------(b)(sj"-----------------------------·-·1 M es sages , i----------------·-·(b.j(GY°-·-·-·-·-·-·-·-·1 L--------------------------------------------------------------------------------

From: cookee@who.int 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages">, Stephen Hahn C.~-~-~-~-~-~-1ilj~L~-~-~-~-~-~1 

Date: Sat, 12 Dec 2020 10:31 :31 -0500 

Congratulations! Excellent press conference today. Best wishes, Erner Cooke 

FDA-OC_FOl_2020-6423_000690 
2020-12-12 16:38:22 UTC: i (b)(G) i Messages-> [ coo kee@wh o. int] •----------------------------------------------------------------------------·-· 

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

To: cookee@who.int 

Date: Sat, 12 Dec 2020 11 :38:22 -0500 

Thx Erner. Best, Steve 

FDA-OC_FOl_2020-6423_000691 
2020-12-12 16:44:50 UTC: i (b)(G) i Messages-> 

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

From: Gayle King :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

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

Date: Sat, 12 Dec 2020 11 :44:50 -0500 

"Big old slow turtle " ?? Good lord ... this president does not make it easy does he? .... yet you're the one playing games 

??? Hang in there Stephen you will be on the right side of history for dotting the l's and crossing the T's .... hopefully this 

will all be over sooner rather later ... 

FDA-OC_FOl_2020-6423_000692 
2020-12-12 16:45:37 UTC: i (b)(G) i Messages-> 

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

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

To: Gayle King :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·1 messages"> 

Date: Sat, 12 Dec 2020 11 :45:37 -0500 

Thank you 

FDA-OC_FOl_2020-6423_000693 
2020-12-12 17:03:44 UTC: i (b)(G) i Messages-> 

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

From: Gayle King :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

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

Date: Sat, 12 Dec 2020 12:03:44 -0500 

Seriously hang in there ... you know who you are and your intentions ... 

FDA-OC_FOl_2020-6423_000694 
2020-12-12 17:18:38 UTC: i (b)(G) i Messages-> 

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

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

To: Gayle King :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·1 messages"> 

Date: Sat, 12 Dec 2020 12:18:38 -0500 

For sure. Not just intentions - also actions. 

FDA-OC_FOl_2020-6423_000695 
2020-12-12 17:51 :08 UTC: i (b)(G) i Messages-> 

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

From: Gayle King :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

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

Date: Sat, 12 Dec 2020 12:51 :08 -0500 

Believe me people with brains get that.... 

FDA-OC_FOl_2020-6423_000696 
2020-12-12 17:51 :47 UTC: i (b)(G) i Messages-> 

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

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

To: Gayle King :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·1 messages"> 

Date: Sat, 12 Dec 2020 12:51 :4 7 -0500 

Definitely 

FDA-OC_FOl_2020-6423_000697 
2020-12-12 17:52:25 UTC: i (b)(G) i Messages-> 

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

From: Gayle King :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

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

Date: Sat, 12 Dec 2020 12:52:25 -0500 

And a lot of us have brains 

FDA-OC_FOl_2020-6423_000698 
2020-12-12 17:53:19 UTC: i (b)(G) i Messages-> 

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

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

To: Gayle King :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·1 messages"> 

Date: Sat, 12 Dec 2020 12:53:19 -0500 

So true. And ita€TMs insulting to think otherwise. Thank you for what you do to keep the American public informed and 

safe 

FDA-OC_FOl_2020-6423_000699 
2020-12-12 17:54:03 UTC: i (b)(G) i Messages-> 

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

From: Gayle King :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

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

Date: Sat, 12 Dec 2020 12:54:03 -0500 

Back at you doctor! 

FDA-OC_FOl_2020-6423_000700 
2020-12-15 10:41 :42 UTC: i (b)(G) i Messages-> 

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

From: Robert Ford [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Tue, 15 Dec 2020 05:41 :42 -0500 

Just wanted to say congratulations on the vaccine approval and thank you and your team for everything you guys have 

done this year. And specifically for all that you have had to endure. Hope all is well with you and your family. Stay well. 

- Robert Ford {Abbott} 

FDA-OC_FOl_2020-6423_000701 
2020-12-15 12:32:07 UTC: i (b)(G) i Messages-> 

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

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

To: Robert Ford [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 15 Dec 2020 07:32:07 -0500 

Robert, really great to hear from you. Thank you for your kind words and for all that you and your team have done and 

are doing as part of our nation's response. 

FDA-OC_FOl_2020-6423_000702 
2020-12-17 13:22:45 UTC: i (b)(G) i Messages -> 

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

From: 

To: 

Date: 

Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Thu, 17 Dec 2020 08:22:45 -0500 

Dr Hahn. This is Brian Rudick with Honeywell. John Waldron asked,.me_to_ reach out to you after he just finished a call with 

WH CoS who asked what needs to be done for us to be able to shi1LlbJ(4)__jmasks today. I've had calls yesterday with FDA 

and HHS. I wanted to bring you up to speed and solicit your guidance on how best to try to solve this. 

I know you are super busy but Would appreciate if you could call me back to discuss for a few min. Many thanks. -Brian 

FDA-OC_FOl_2020-6423_000703 
2020-12-17 13:48:32 UTC: i (b)(G) i Messages -> 

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

From: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Thu, 17 Dec 2020 08:48:32 -0500 

Super appreciate your time ... please ask your team if 21 CFR 801.128 would work to allow FDA center director to grant 

an exception for labeling for product going to national stockpile 

FDA-OC_FOl_2020-6423_000704 
2020-12-17 14:10:38 UTC: i (b)(G) i Messages-> 

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

From: 

To: 

Date: 

Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Thu, 17 Dec 2020 09:10:38-0500 

I confirmed with my team tbat_H!:1$ has told us that the products need to be commercially packaged to go to health care 

facilities - thata€TMs for thi(bH3J,(bH4liorder. We believe the same for FEMA but we havena€TMt had the same interaction with 

them. Will try to further conlfrm-·-·· 

FDA-OC_FOl_2020-6423_000705 
2020-12-17 14:14:38 UTC: i (b)(G) i Messages-> 

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

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

To: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Thu, 17 Dec 2020 09:14:38-0500 

Does this mean SNS and then to health care facilities or directly to health care facilities? 

FDA-OC_FOl_2020-6423_000706 
2020-12-17 14:18:39 UTC: i (b)(G) i Messages-> 

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

From: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Thu, 17 Dec 2020 09:18:39-0500 

i ___ afHHSlo"lryli5"g1ve-·you·-greafer·-c1iirity"h~!~~-L-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·___i I've put in a call to my contact 

FDA-OC_FOl_2020-6423_000707 
2020-12-17 14:22:14 UTC: i (b)(G) i Messages-> 

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

From: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Thu, 17 Dec 2020 09:22:14 -0500 

Can you provide me with your email address so I can forward you the labels so your team can review? 

FDA-OC_FOl_2020-6423_000708 
2020-12-17 14:22:37 UTC: i (b)(G) i Messages-> 

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

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

To: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Thu, 17 Dec 2020 09:22:37 -0500 

sh1@fda.HHS.gov 

FDA-OC_FOl_2020-6423_000709 
2020-12-17 14:33:21 UTC: i (b)(G) i Messages-> 

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

From: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Thu, 17 Dec 2020 09:33:21 -0500 

Thx 

FDA-OC_FOl_2020-6423_000710 
2020-12-17 15:12:07 UTC: i (b)(G) i Messages-> 

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

From: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Thu, 17 Dec 2020 10:12:07 -0500 

Spoke with David Kelley at HHS. He confirmed that both HHS and FEMA contracts are for strategic national stockpile and 

will used to fulfill requests- primarily from health care facilities and states etc ... 

FDA-OC_FOl_2020-6423_000711 
2020-12-17 15:12:37 UTC: i (b)(G) i Messages-> 

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

From: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Thu, 17 Dec 2020 10:12:37 -0500 

Just sent artwork for boxes we use for the mask( __________________________________ (b)(4) _________________________________ ___: 

FDA-OC_FOl_2020-6423_000712 
2020-12-17 15:12:41 UTC: i (b)(G) i Messages-> 

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

From: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Thu, 17 Dec 2020 10:12:41 -0500 

Hope that helps 

FDA-OC_FOl_2020-6423_000713 
2020-12-17 16:20:07 UTC: i (b)(G) i Messages -> 

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

From: 

To: 

Date: 

Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Thu, 17 Dec 2020 11 :20:07 -0500 

.--~lust.Jioic;;h~d meeting with FDA team on the other two combinations.nnin.a..thrnqgh Appendix A. We also discussed 

:_ _____ (!>J1~L,.Jabel issue. From a priority standpoint, allowing us to shili_ _____ JI_?.}(<:!) ___ __.! masks under a waiver is more impactful 

than getting Appendix A inclusion for other two combos in short term. We obviously needs both but wanted you to get a 

sense of priority from us. 

FDA-OC_FOl_2020-6423_000714 
2020-12-17 20:57:36 UTC: i (b)(G) i Messages-> 

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

From: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Thu, 17 Dec 2020 15:57:36-0500 

We have provided the requested information to your team so hopefully they have everything they need now 

FDA-OC_FOl_2020-6423_000715 
2020-12-17 21 :06:00 UTC: i (b)(G) i Messages-> 

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

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

To: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Thu, 17 Dec 2020 16:06:00 -0500 

Thank you 

FDA-OC_FOl_2020-6423_000716 
2020-12-17 21 :07:11 UTC: i (b)(G) i Messages-> 

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

From: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Thu, 17 Dec 2020 16:07:11 -0500 

Liked ''Thank you " 

FDA-OC_FOl_2020-6423_000717 
2020-12-17 22:09:37 UTC: i (b)(G) i Messages-> 

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

From: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Thu, 17 Dec 2020 17:09:37 -0500 

Your team is amazing 

FDA-OC_FOl_2020-6423_000718 
2020-12-17 22:09:45 UTC: i (b)(G) i Messages-> 

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

From: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Thu, 17 Dec 2020 17:09:45 -0500 

I think we got there 

FDA-OC_FOl_2020-6423_000719 
2020-12-17 22:09:54 UTC: i (b)(G) i Messages-> 

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

From: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Thu, 17 Dec 2020 17:09:54 -0500 

We are working to memorials 

FDA-OC_FOl_2020-6423_000720 
2020-12-17 22:10:00 UTC: i (b)(G) i Messages-> 

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

From: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Thu, 17 Dec 2020 17:10:00 -0500 

Memorialize 

FDA-OC_FOl_2020-6423_000721 
2020-12-18 01 :04:49 UTC: i (b)(G) i Messages -> 

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

From: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Thu, 17 Dec 2020 20:04:49 -0500 

Not trying to overly rush anyone but really hoping we can get to DLA tonight. Any sense of how much longer with your 

team and then who best to contact at DLA? 

FDA-OC_FOl_2020-6423_000722 
2020-12-18 17:12:00 UTC: i (b)(G) i Messages-> 

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

From: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Fri, 18 Dec 2020 12:12:00 -0500 

Had a call with your working team this am and just provided our response. Ask from us is to get appendix a for the other 

two combos and similar enforcement discretion letter by EOD - assuming you and your team are comfortable. 

FDA-OC_FOl_2020-6423_000723 
2020-12-18 17:39:23 UTC: i (b)(G) i Messages -> 

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

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

To: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Fri, 18 Dec 2020 12:39:23 -0500 

Got it and thanks 

FDA-OC_FOl_2020-6423_000724 
2020-12-18 17:39:58 UTC: i (b)(G) i Messages -> 

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

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

To: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Fri, 18 Dec 2020 12:39:58 -0500 

Let me know if you you run into obstacles 

FDA-OC_FOl_2020-6423_000725 
2020-12-18 17:41 :49 UTC: i (b)(G) i Messages-> 

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

From: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Fri, 18 Dec 2020 12:41:49-0500 

Will do 

FDA-OC_FOl_2020-6423_000726 
2020-12-18 22:22:09 UTC: i (b)(G) i Messages-> 

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

From: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Fri, 18 Dec 2020 17:22:09 -0500 

So DLA has just lifted the stop work order which is great news! We are cleared to ship the private label mask. Only thing 

left is getting appendix a approval on last two combos and enforcement discretion so we can ship the HON masks. Could 

you check in with your team when you have a moment? 

FDA-OC_FOl_2020-6423_000727 
2020-12-18 22:27:37 UTC: i (b)(G) i Messages-> 

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

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

To: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Fri, 18 Dec 2020 17:27:37 -0500 

Absolutely. Dealing with another issue right now but will get back to you 

FDA-OC_FOl_2020-6423_000728 
2020-12-18 22:27:56 UTC: i (b)(G) i Messages-> 

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

From: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Fri, 18 Dec 2020 17:27:56 -0500 

Ok - and totally understand 

FDA-OC_FOl_2020-6423_000729 
2020-12-19 00:31 :08 UTC: i (b)(G) i Messages-> 

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

From: 

To: 

Date: 

Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Fri, 18 Dec 2020 19:31 :08 -0500 

When you ~ome up for air ... w,e spoke witlf{bii-1.f-who has provided us with_the 25 gsm spunbond that your_tearr;i __ i§._~_5-~i_!:1_g _____ , 

about. We Just had the GM of LlbJ(4)_i send a-sfafement to your team confirming that they supply s~.m-~ __ 1]1atenal to (b)(4) ! 

other Leading face mask manufactures with 510k cleared products. Hoping this is enough for th~.J~)_(~.l! formulat\"on:-·we·-·-·-·-·' 

have a second formulation with Superior material and doesna€TMt sound like there are any questions there so maybe 

thata€TMs easier to do now? 

FDA-OC_FOl_2020-6423_000730 
2020-12-19 13:58:16 UTC: i (b)(G) i Messages-> 

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

From: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Sat, 19 Dec 2020 08:58:16 -0500 

Good morning Steve. Can we touch base when you have a couple of minutes? 

FDA-OC_FOl_2020-6423_000731 
2020-12-19 14:02:52 UTC: i (b)(G) i Messages-> 

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

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

To: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Sat, 19 Dec 2020 09:02:52 -0500 

For sure. I have a member of Congress call and a governors call this morning. Can call after those calls. I spoke to the 

team last night. Any additional information from your perspective? 

FDA-OC_FOl_2020-6423_000732 
2020-12-19 14:03:12 UTC: i (b)(G) i Messages-> 

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

From: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Sat, 19 Dec 2020 09:03:12 -0500 

For sure 

FDA-OC_FOl_2020-6423_000733 
2020-12-19 14:10:46 UTC: i (b)(G) i Messages-> 

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

From: 

To: 

Date: 

Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Sat, 19 Dec 2020 09:10:46 -0500 

I can give you more detail when we speak but I think it's largely consistent with .. my prior.text last night. The only other bit 

of information that I can share is that your team spoke with somebody a~ (b)(4) i3fter: Jl?.K4Jjubmitted the additional 

information. I'm hoping that's all that wa~_•-eaded.for that combination. Ntirawa're of any issues on the second 

combination involving superior. We hav~ (b)(4) jmass involving that combination ready to ship upon appendix a approval. L--·-·-·-·-·-·-·-·-·-·' 

FDA-OC_FOl_2020-6423_000734 
2020-12-19 17:39:08 UTC: i (b)(G) i Messages -> 

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

From: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Sat, 19 Dec 2020 12:39:08 -0500 

. ·-·-·-·-·-·-·-, 

Just sent more info to your team around noon and o thinl (b)(4) palling them as well to discuss additional info requested by your team to them. '-·-·-·-·-·-·-·" 

FDA-OC_FOl_2020-6423_000735 
2020-12-19 21 :07:57 UTC: i (b)(G) i Messages-> 

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

From: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Sat, 19 Dec 2020 16:07:57 -0500 

Specifically here's what we said: 

That said, if yaur:.team.feels.lhat.AnoP.nd~ A listing for Combination 3i (b )( 4) ! is not possible today and that 

Combination~ (b)(4) : can be listed on Appendix )Uoday~·1nen·w1ii"woi.ild request FDA to: (a) list 

Combination 2·-·-·-·-···-·-·-·-·-·-·-·~---·-·-·-·-·-·-·,·-·-·-·-·-·_: on_ the_ EU A Appendix_ A; (b) exercise its enforcement discretion to not object to 

the use and distfjbu.tioo_of..Comhioatil:;m 2 'f (b)(4) r in its existing packaging/labeling while working on 

Combination 3 'L._ ___________ __(b )( 4) ·-·-·-·-·-·-___! •·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-' 

FDA-OC_FOl_2020-6423_000736 
2020-12-20 01 :03:04 UTC: i (b)(G) i Messages-> 

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

From: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Sat, 19 Dec 2020 20:03:04 -0500 

We got both letters from your team. I was going to call but it sounded like you might be in an event and I didn't want to 

disturb you. 

FDA-OC_FOl_2020-6423_000737 
2020-12-20 01 :03:33 UTC: i (b)(G) i Messages-> 

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

From: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Sat, 19 Dec 2020 20:03:33 -0500 

We can't thank you enough for your personal engagement on this matter. To say you made a difference in the lives of so 

many people is a gross understatement. 

FDA-OC_FOl_2020-6423_000738 
2020-12-20 01 :03:55 UTC: i (b)(G) i Messages-> 

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

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

To: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Sat, 19 Dec 2020 20:03:55 -0500 

I am very happy this got done 

FDA-OC_FOl_2020-6423_000739 
2020-12-20 01 :03:58 UTC: i (b)(G) i Messages-> 

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

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

To: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Sat, 19 Dec 2020 20:03:58 -0500 

Congratulations 

FDA-OC _FOl_2020-6423_0007 40 
2020-12-20 01 :04:08 UTC: i (b)(G) i Messages-> 

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

From: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Sat, 19 Dec 2020 20:04:08 -0500 

Liked "Congratulations " 

FDA-OC_FOl_2020-6423_0007 41 
2020-12-20 19:24:11 UTC: i (b)(G) i Messages-> 

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

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

To: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Sun, 20 Dec 2020 14:24:11 -0500 

FYI 

Thank you Mr. Adamczyk. We have a great team. I'd like to give a shout out to Brian Ruddick who was great to work with 

and helped us get this over the finish line. Happy Holidays. 

Steve 

FDA-OC _FOl_2020-6423_0007 42 
2020-12-20 19:28:03 UTC: i (b)(G) i Messages-> 

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

From: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Sun, 20 Dec 2020 14:28:03 -0500 

So nice of you to do that. Thank you! Needless to say I also sang your praises and emphasized that I think we chatted 

~bout 20X in 3 d~ys.l've never s~~QJb.at type of p~rsonal engage~~Q1.~_Q<J_l~8-Q~!.~hip_.fr:_qr.rr_P..QY9.!.!.~.Jri __ ~--~~nior position 

like you hold. I think we are up tq_lb)(4)Jmasks leaving on Monday i._ __________________________________ (!>).{~) ___________________________________ j 

FDA-OC _FOl_2020-6423_0007 43 
2020-12-20 19:38:50 UTC: i (b)(G) i Messages-> 

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

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

To: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Sun, 20 Dec 2020 14:38:50 -0500 

Well my best wishes with the logistics and happy holidays 

FDA-OC _FOl_2020-6423_0007 44 
2020-12-20 19:39:11 UTC: i (b)(G) i Messages-> 

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

From: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Sun, 20 Dec 2020 14:39:11 -0500 

Thanks and you too! 

FDA-OC _FOl_2020-6423_0007 45 
2020-12-21 17:59:03 UTC: i (b)(G) i Messages -> 

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

From: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Mon, 21 Dec 2020 12:59:03 -0500 

Wanted to share this picture with you. I'm on site as we are loading trucks now with supplemental label on pallets. Masks 

are steadying to move! 

FDA-OC _FOl_2020-6423_0007 46 
FDA-OC _FOl_2020-6423_0007 4 7 
2020-12-21 18:04:31 UTC: i (b)(G) i Messages -> 

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

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

To: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Mon, 21 Dec 2020 13:04:31 -0500 

Liked "Wanted to share this picture with you. I'm on site as we are loading trucks now with supplemental label on pallets. 

Masks are steadying to move! 

FDA-OC _FOl_2020-6423_0007 48 
2020-12-21 18:04:35 UTC: i (b)(G) i Messages -> 

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

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

To: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Mon, 21 Dec 2020 13:04:35 -0500 

That is so great 

FDA-OC _FOl_2020-6423_0007 49 
2021-01-16 16:48:07 UTC: i (b)(G) i Messages -> 

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

From: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Sat, 16 Jan 2021 11:48:07 -0500 

Hope you are doing well. Reading some crazy things. Stay strong! We really appreciate all of your leadership. If we can 

be of any help in any way, don't hesitate to reach out 

FDA-OC_FOl_2020-6423_000750 
2021-01-16 16:49:13 UTC: i (b)(G) i Messages-> 

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

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

To: Brian Ruddick [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Sat, 16 Jan 2021 11:49:13-0500 

Thx Brian 

FDA-OC_FOl_2020-6423_000751 
2020-12-20 02:29:04 UTC: john.waldron@honeywell.com -> 

l _______________________________ Jb )( 6 > -----------------------------·-· ! Messages, !__ ________________ ( b )( G > _________________ ! 

From: john.waldron@honeywell.com 

To: Stephen Hahn :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages">, Stephen Hahn C.~-~-~-~-~-~-1ilj~L~-~-~-~-~-~1 

Date: Sat, 19 Dec 2020 21 :29:04 -0500 

Dr Hahn - Brian Rudick let me know that you worked super hard and partnered tremendously well getting things cleared 

up so masks can begin shipping to those who need them most. You and the FDA are doing critically important things in 

this extremely challenging time. Your personal approach and commitment makes a big difference. Thanks again and 

Happy Holidays! 

FDA-OC_FOl_2020-6423_000752 
2020-12-20 15:02:43 UTC: i (b)(G) i Messages-> 

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

From: l·-·-·-·-·-·-·-·-·-·~(iiWlf·-·-·-·-·-·-·-·-·-·1 messages" 

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

Date: Sun, 20 Dec 2020 10:02:43 -0500 

Dr. Hahn - this is Darius Adamczyk - CEO of Honeywell. Just wanted to say thank you for your personal assistance and 

the hard work of your staff in resolving our surgical mask matter so quickly this week. We hope this helps get these 

critical supplies to those most in need. We are very grateful for FDA's leadership during the pandemic. Happy Holidays 

Darius 

FDA-OC_FOl_2020-6423_000753 
2020-12-20 19:23:44 UTC: i (b)(G) i Messages-> 

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

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

To: [·-·-·-·-·-·-·-·-·-·~(iiWlf·-·-·-·-·-·-·-·-·-·1 messages" 

Date: Sun, 20 Dec 2020 14:23:44 -0500 

Thank you Mr. Adamczyk. We have a great team. I'd like to give a shout out to Brian Ruddick who was great to work with 

and helped us get this over the finish line. Happy Holidays. 

Steve 

FDA-OC_FOl_2020-6423_000754 
2021-01-07 20:50:18 UTC: i (b)(G) i Messages-> 

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

From: Anand Shah [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Thu, 07 Jan 2021 15:50:18 -0500 

Just reminder for WHTF email for AEG update. Starting in 10 min. Thanks. 

FDA-OC_FOl_2020-6423_000755 
2021-01-07 21 :18:55 UTC: i (b)(G) i Messages-> 

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

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

To: Anand Shah [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Thu, 07 Jan 2021 16:18:55 -0500 

I sent 

FDA-OC_FOl_2020-6423_000756 
2021-01-07 21 :20:53 UTC: i (b)(G) i Messages -> 

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

From: Anand Shah [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Thu, 07 Jan 2021 16:20:53 -0500 

Hi. It didn't come through. Maybe hung up on server. Don't worry about it - maybe you can update on tomorrow's 9am 

FDA-OC_FOl_2020-6423_000757 
2021-01-07 21 :21 :03 UTC: i (b)(G) i Messages -> 

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

From: Anand Shah [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Thu, 07 Jan 2021 16:21:03-0500 

Sorry about that 

FDA-OC_FOl_2020-6423_000758 
2021-01-07 21 :21 :43 UTC: i (b)(G) i Messages -> 

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

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

To: Anand Shah [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Thu, 07 Jan 2021 16:21:43-0500 

Ugh so sorry 

FDA-OC_FOl_2020-6423_000759 
2021-01-07 21 :21 :46 UTC: i (b)(G) i Messages -> 

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

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

To: Anand Shah [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Thu, 07 Jan 2021 16:21:46-0500 

My bad 

FDA-OC_FOl_2020-6423_000760 
2021-01-07 21 :21 :56 UTC: i (b)(G) i Messages -> 

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

From: Anand Shah [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Thu, 07 Jan 2021 16:21 :56 -0500 

No problem! 

FDA-OC_FOl_2020-6423_000761 
2021-01-17 13:10:25 UTC: i (b)(G) i Messages-> 

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

From: [·-·-·-·-·-·-·-·-·-·~(iiWlf·-·-·-·-·-·-·-·-·-·1 messages" 

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

Date: Sun, 17 Jan 2021 08:10:25 -0500 

Good Morning!! 

It's Linda Mays Mccaul. Michael gave me your contact! 

I have a patient a~ (b )(6) i hospital il·==l~Ji~f·:~~-iwith a severe case of Covid . We had Exoflo divered to administer 

treatment. We have·ffeei,-waiting for FDA Appeoval because we are still in stave 2 trials. No my luck. 

And ideas? 

Linda Mays Mccaul 

FDA-OC_FOl_2020-6423_000762 
2021-01-17 13: 11 :27 UTC: i (b)(G) i Messages -> 

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

From: [·-·-·-·-·-·-·-·-·-·~(iiWlf·-·-·-·-·-·-·-·-·-·1 messages" 

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

Date: Sun, 17 Jan 2021 08: 11 :27 -0500 

We need eNID approval 

FDA-OC_FOl_2020-6423_000763 
2021-01-1717:51:11 UTC: i (b)(G) i Messages-> 

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

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

To: [·-·-·-·-·-·-·-·-·-·~(iiWlf·-·-·-·-·-·-·-·-·-·1 messages" 

Date: Sun, 17 Jan 2021 12:51 :11 -0500 

Do you know the name of the doctor who submitted the request? 

FDA-OC_FOl_2020-6423_000764 
2021-01-17 17:53:46 UTC: i (b)(G) i Messages -> 

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

From: [·-·-·-·-·-·-·-·-·-·~(iiWlf·-·-·-·-·-·-·-·-·-·1 messages" 

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

Date: Sun, 17 Jan 2021 12:53:46 -0500 

Morning!!!!! We got it approved! He's getting his first injection right now!!! Red tape for sure but as we all know it's in 

phase 2. Thank you for your text!!! __ _ 

Linda 

FDA-OC_FOl_2020-6423_000765 
2021-01-17 17:54:07 UTC: i (b)(G) i Messages -> 

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

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

To: [·-·-·-·-·-·-·-·-·-·~(iiWlf·-·-·-·-·-·-·-·-·-·1 messages" 

Date: Sun, 17 Jan 2021 12:54:07 -0500 

Good news 

FDA-OC_FOl_2020-6423_000766 
2021-01-17 17:55:33 UTC: i (b)(G) i Messages -> 

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

From: [·-·-·-·-·-·-·-·-·-·~(iiWlf·-·-·-·-·-·-·-·-·-·1 messages" 

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

Date: Sun, 17 Jan 2021 12:55:33 -0500 

Yes thank you! I hope you didn't mind Michael giving me your number! 

FDA-OC_FOl_2020-6423_000767 
2021-01-17 17:56:01 UTC: i (b)(G) i Messages -> 

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

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

To: [·-·-·-·-·-·-·-·-·-·~(iiWlf·-·-·-·-·-·-·-·-·-·1 messages" 

Date: Sun, 17 Jan 2021 12:56:01 -0500 

No worries at all. My personal cell is! (b)(6) ] L---·-·-·-·-·-·-·-·-·-·-·-·-·-·-' 

FDA-OC_FOl_2020-6423_000768 
2021-01-17 17:56:13 UTC: i (b)(G) i Messages-> 

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

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

To: [·-·-·-·-·-·-·-·-·-·~(iiWlf·-·-·-·-·-·-·-·-·-·1 messages" 

Date: Sun, 17 Jan 2021 12:56:13 -0500 

Please share with the Congressman 

FDA-OC_FOl_2020-6423_000769 
2021-01-17 17:56:31 UTC: i (b)(G) i Messages -> 

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

From: [·-·-·-·-·-·-·-·-·-·~(iiWlf·-·-·-·-·-·-·-·-·-·1 messages" 

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

Date: Sun, 17 Jan 2021 12:56:31 -0500 

Thank you!!!!! 

FDA-OC_FOl_2020-6423_000770 
2021-01-19 19:43:36 UTC: i (b)(G) i Messages -> 

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

From: 

To: 

Date: 

Hello Dr. Hahn. 

Jason Duncans :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

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

Tue, 19 Jan 2021 14:43:36 -0500 

Just wanted to send you a note thanking you for your service. 

When my former company (Outdoor Research) first worked our way through FDA's ever changing and frustrating 

regulations I appreciated you were in an unenviable position. However you were always_a_straiahi broker regardless of 

the political implications. I am now working with FLTR Inc, the lar!;lest_supplier of PPE_td ___ JblL4) More_ FDA_regulations 

in my future as we move from masks, thermometers, and N95s to! (b)(4) under our 

brand as the specification developer. I hope your successor has calmeYwatefslcYs·anr·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·' 

I can only wish you and your family all the best in the future! Perhaps some rest in recovery from this ridiculously 

turbulent year! 

Jason Duncan 

VP Government Sales 

FLTR Inc 

www.FLTR.com 

Seattle, WA 

FDA-OC_FOl_2020-6423_000771 
2021-01-21 13:29:53 UTC: i (b)(G) i Messages -> 

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

From: [·-·-·-·-·-·-·-·-·-·~(iiWlf·-·-·-·-·-·-·-·-·-·1 messages" 

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

Date: Thu, 21 Jan 2021 08:29:53 -0500 

Steve - it was a pleasure working with you on Convalescent plasma. I think you were a great commissioner who was in 

the right place for these tough times. Thanks for serving - I know it was a huge pay cut but you are a patriot and a great 

American. Please stay in touch. Scott Wright 

FDA-OC_FOl_2020-6423_000772 
2020-05-14 12:43:51 UTC: i (b)(G) i Messages-> 

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

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

To: Amy Abernethy [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Thu, 14 May 2020 08:43:51 -0400 

https://www.medrxiv.org/content/10 .1101 /2020.05.02.20080036v1 

FDA-OC_FOl_2020-6423_000928 
2020-05-14 12:44:10 UTC: i (b)(G) i Messages-> 

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

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

To: Amy Abernethy [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Thu, 14 May 2020 08:44:10 -0400 

Amy, not peer reviewed but are you aware of this? 

FDA-OC_FOl_2020-6423_000929 
2020-07-17 16:43:11 UTC: i (b)(G) i Messages-> 

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

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

To: Colin Rom C~~~~~~~~~~j~~li~L~~~~~~~~~~~J@native messages">, Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Fri, 17 Jul 2020 12:43:11 -0400 

Need to add serology EUA guidance revision to the AMA meeting agenda 

FDA-OC_FOl_2020-6423_000935 
2020-07-17 16:43:23 UTC: i (b)(G) i Messages-> 

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

From: Colin Rom C~~~~~~~~~~i~ii~L~~~~~~~~~~]@native messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Fri, 17 Jul 2020 12:43:23 -0400 

On it 

FDA-OC_FOl_2020-6423_000936 
2020-07-17 16:43:25 UTC: i (b)(G) i Messages-> 

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

From: Colin Rom C~~~~~~~~~~i~ii~L~~~~~~~~~~]@native messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Fri, 17 Jul 2020 12:43:25 -0400 

Will ad 

FDA-OC_FOl_2020-6423_000937 
2020-07-17 16:43:28 UTC: i (b)(G) i Messages-> 

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

From: Colin Rom C~~~~~~~~~~i~ii~L~~~~~~~~~~]@native messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Fri, 17 Jul 2020 12:43:28 -0400 

Add* 

FDA-OC_FOl_2020-6423_000938 
2020-07-17 16:43:31 UTC: i (b)(G) i Messages-> 

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

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

To: Colin Rom C~~~~~~~~~~j~~li~L~~~~~~~~~~~J@native messages">, Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jiij(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Fri, 17 Jul 2020 12:43:31 -0400 

Thx 

FDA-OC_FOl_2020-6423_000939 
2020-07-23 13:16:52 UTC: i (b)(G) i Messages-> 

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

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

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

Date: Thu, 23 Jul 2020 09:16:52 -0400 

Where are they? 

FDA-OC_FOl_2020-6423_000940 
2020-07-23 13:17:28 UTC: i (b)(G) i Messages-> 

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

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

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

Date: Thu, 23 Jul 2020 09:17:28 -0400 

Colin can you print me an agenda for the 1-1 

FDA-OC_FOl_2020-6423_000941 
2020-07-28 13:04:32 UTC: i (b)(G) i Messages-> 

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

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

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Tue, 28 Jul 2020 09:04:32 -0400 

Reminder for tonightFDA-OC_FOl_2020-6423_000942 
2020-07-28 13:04:34 UTC: i (b)(G) i Messages-> 

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

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

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Tue, 28 Jul 2020 09:04:34 -0400 

https://abcnews.go.com/US/video/american-catastrophe-tuesday-98c-abc-71925166 

FDA-OC_FOl_2020-6423_000943 
FDA-OC_FOl_2020-6423_000944 
2020-07-28 13:04:44 UTC: i (b)(G) i Messages-> 

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

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

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

Date: Tue, 28 Jul 2020 09:04:44 -0400 

Thx 

FDA-OC_FOl_2020-6423_000945 
2020-07-28 13:04:56 UTC: i (b)(G) i Messages-> 

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

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

To: John Wagner [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Tue, 28 Jul 2020 09:04:56 -0400 

Thx 

FDA-OC_FOl_2020-6423_000946 
2020-09-05 20:28: 13 UTC: i ________________________________ (b)(G) ________________________________ i Messages -> [3 

recipients] 

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

To: Colin Rom :-·-·-·-·-·-·-b -· 6 ·-·-·-·-·-·-·:@native messages">, Anand Shah r·-·-·-·-·-·-·-·-·-·-·-·ti-·s-·-·-·-·-·-·-·-·-·-·-·1 messages">, Keagan ; ( )( ) , '·-·-·-·-·-·-·-·-·-·-.J-J~.L. _________________ _ Lenihan [·-·--·-·-·-·-·-·-·-_(b)(S) ··-·-·-·-··-·-·-·-·-·1 messages"> 

Date: Sat, 05 Sep 2020 16:28:13 -0400 

Do we have the tweets ready? 

FDA-OC_FOl_2020-6423_000953 
2020-09-05 20: 29: 06 U TC: ! ________________________________ ( b )( s ) ________________________________ ! Messages -> [3 

recipients] 

From: Anand Shah [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Colin Rom :-·-·-·-·-·-·-b -· 6 ·-·-·-·-·-·-·:@native messages">, Stephen Hahn r·-·-·-·-·-·-·-·-·-·-·-·ti-·s-·-·-·-·-·-·-·-·-·-·-·1 messages">, K L •-~ff ·-·--tJLL_,_,_,_,J _____________________________ " II '·-·-·-·-·-·-·-·-·-·-__(_J~.L. _________________ _ 

eagan em an l_________________(b)(S) ·-·-·-·-·-·-·-·-·-·-: messages > 

Date: Sat, 05 Sep 2020 16:29:06 -0400 

Peter signed off. Moving through ace clearance 

FDA-OC_FOl_2020-6423_000954 
2020-09-05 20: 29: 32 U TC: ! ________________________________ ( b )( s ) ________________________________ ! Messages -> [3 

recipients] 

From: Anand Shah [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Colin Rom :-·-·-·-·-·-·-b -· 6 ·-·-·-·-·-·-·:@native messages">, Stephen Hahn r·-·-·-·-·-·-·-·-·-·-·-·ti-·s-·-·-·-·-·-·-·-·-·-·-·1 messages">, K L •-~ff ·-·--tJLL_,_,_,_,J _____________________________ " II '·-·-·-·-·-·-·-·-·-·-__(_J~.L. _________________ _ 

eagan em an l_________________(b)(S) ·-·-·-·-·-·-·-·-·-·-: messages > 

Date: Sat, 05 Sep 2020 16:29:32 -0400 

Colin, do you have a pulse on timing ? 

FDA-OC_FOl_2020-6423_000955 
2020-09-05 20: 29: 45 U TC: ! ________________________________ ( b )( s ) ________________________________ ! Messages -> [3 

recipients] 

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

To: Colin Rom :-·-·-·-·-·-·-b -· 6 ·-·-·-·-·-·-·:@native messages">, Anand Shah r·-·-·-·-·-·-·-·-·-·-·-·ti-·s-·-·-·-·-·-·-·-·-·-·-·1 messages">, Keagan ; ( )( ) , '·-·-·-·-·-·-·-·-·-·-.J-J~.L. _________________ _ Lenihan [·-·--·-·-·-·-·-·-·-_(b)(S) ··-·-·-·-··-·-·-·-·-·1 messages"> 

Date: Sat, 05 Sep 2020 16:29:45 -0400 

I thought ace already reviewed? 

FDA-OC_FOl_2020-6423_000956 
2020-09-05 20: 37: 04 UTC: ! ________________________________ (b )(G) ________________________________ i Messages -> [3 

recipients] 

From: Anand Shah [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Colin Rom :-·-·-·-·-·-·-b -· 6 ·-·-·-·-·-·-·:@native messages">, Stephen Hahn r·-·-·-·-·-·-·-·-·-·-·-·ti-·s-·-·-·-·-·-·-·-·-·-·-·1 messages">, K L •-~ff ·-·--tJLL_,_,_,_,J _____________________________ " II '·-·-·-·-·-·-·-·-·-·-__(_J~.L. _________________ _ 

eagan em an l_________________(b)(S) ·-·-·-·-·-·-·-·-·-·-: messages > 

Date: Sat, 05 Sep 2020 16:37:04 -0400 

0cc has not seen the first very tweet you crafted which appears benign to me. Sent you final thread by email . Spoke to 

Michael just now and he will defer to you on green light and timing of release 

FDA-OC_FOl_2020-6423_000957 
2020-09-05 20: 3 7: 41 U TC: ! ________________________________ ( b )( s ) ________________________________ ! Messages -> [3 

recipients] 

From: Anand Shah [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Colin Rom :-·-·-·-·-·-·-b -· 6 ·-·-·-·-·-·-·:@native messages">, Stephen Hahn r·-·-·-·-·-·-·-·-·-·-·-·ti-·s-·-·-·-·-·-·-·-·-·-·-·1 messages">, K L •-~ff ·-·--tJLL_,_,_,_,J _____________________________ " II '·-·-·-·-·-·-·-·-·-·-__(_J~.L. _________________ _ 

eagan em an l_________________(b)(S) ·-·-·-·-·-·-·-·-·-·-: messages > 

Date: Sat, 05 Sep 2020 16:37:41 -0400 

Perhaps you can quickly reply all to thread with your input ? 

FDA-OC_FOl_2020-6423_000958 
2020-09-05 20: 58: 01 U TC: ! ________________________________ ( b )( s ) ________________________________ ! Messages -> [3 

recipients] 

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

To: Colin Rom :-·-·-·-·-·-·-b -· 6 ·-·-·-·-·-·-·:@native messages">, Anand Shah r·-·-·-·-·-·-·-·-·-·-·-·ti-·s-·-·-·-·-·-·-·-·-·-·-·1 messages">, Keagan ; ( )( ) , '·-·-·-·-·-·-·-·-·-·-.J-J~.L. _________________ _ Lenihan [·-·--·-·-·-·-·-·-·-_(b)(S) ··-·-·-·-··-·-·-·-·-·1 messages"> 

Date: Sat, 05 Sep 2020 16:58:01 -0400 

Done 

FDA-OC_FOl_2020-6423_000959 
2020-09-09 21 :39:39 UTC: i ________________________________ (b)(G) _____________________________ ___i Messages -> [3 

recipients] 

From: Maren McBride [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Erika Anderson [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Stephen Hahn [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Keagan Lenihan [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Wed, 09 Sep 2020 17:39:39 -0400 

Hi Commissioner- just flagging for you that you have a call with Senator Merkley at 6:35 tonight to discuss the NYTS and 

PMTA application deadline. We gave your TPs to Frank and Jakea. 

Merkley's staff told me he also intends to bring up vaccines. His staff sent over some questions earlier today with some 

status requests and how we will be moving forward (we are working on those) but I think he also intends to press you a bit 

on it as far as following science and data. 

FDA-OC_FOl_2020-6423_000960 
2020-09-09 22: 00: 50 UTC: ! ________________________________ (b )(G) ________________________________ i Messages -> [3 

recipients] 

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

To: Erika Anderson [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Maren McBride [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Keagan Lenihan [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Wed, 09 Sep 2020 18:00:50 -0400 

Okthx 

FDA-OC_FOl_2020-6423_000961 
2020-09-23 12: 39: 4 7 U TC: ! ________________________________ ( b )( s ) ________________________________ ! Messages -> [3 

recipients] 

From: Andrew Tantillo [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Ann K. Abram [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Keagan Lenihan [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Wed, 23 Sep 2020 08:39:47 -0400 

A Warren signature issue is ethics. She introduced a bill to root out conflicts on interest in COVID funding. She'll ask each 

__ of you_ if_y-0u __ have. COi. _She_ may_ also_ ask what protections _in_ place to. prevent.·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- i i 

I (b)(S) I 

i.-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-j 

l.Lf asked··-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ( b )( S) -·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· i 

FDA-OC_FOl_2020-6423_000963 
2020-12-18 12:47:09 UTC: i ________________________________ (b)(G) _____________________________ ___i Messages -> [3 

recipients] 

From: Stephanie Caccamo :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Michael Felberbaum [:::::::::j~i(sf::::::::J messages">, Stephen Hahn [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Fri, 18 Dec 2020 07:47:09 -0500 

FDA-OC_FOl_2020-6423_001010 
• 111 Verizon LTE 7:46 AM 

< Tweet 

Donald J. Trump 0 

@realDonaldTrump 

oderna vaccine overwhelmingly 

approved. Distribution to start 

immediately. 

7:37 AM • 12/18/20 • Twitter for iPhone 

2,506 Retweets 14.5K Likes 

SANA. @sanaonline_ · 7m 

Replying to @realDonaldTrump 

FIGHT FOR TRUMP ISi 

FIGHT FOR TRUMP II 

FIGHT FOR TRUMP II 

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FIGHT FOR TRUMP Iii 

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FIGHT FOR TRUMP ~ 

Tweet your reply 

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FDA-OC_FOl_2020-6423_001011 
2020-12-18 12:47:32 UTC: i ________________________________ (b)(G) _____________________________ ___i Messages -> [3 

recipients] 

From: Stephanie Caccamo :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Michael Felberbaum [:::::::::j~i(sf::::::::J messages">, Stephen Hahn [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

Date: Fri, 18 Dec 2020 07:47:32 -0500 

FYI 

FDA-OC_FOl_2020-6423_001012 
2020-12-18 12:48:00 UTC: i ________________________________ (b)(G) _____________________________ ___i Messages -> [3 

recipients] 

From: Keagan Lenihan [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Michael Felberbaum [:::::::::j~i(sf::::::::J messages">, Stephen Hahn [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Stephanie Caccamo [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Fri, 18 Dec 2020 07:48:00 -0500 

Thx. 

FDA-OC_FOl_2020-6423_001013 
2020-12-18 12:50:52 UTC: i ________________________________ (b)(G) ________________________________ i Messages -> [3 

recipients] 

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

To: Michael Felberbaum [:::::::::j~i(sf::::::::J messages">, Stephanie Caccamo [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·1 messages"> 

Date: Fri, 18 Dec 2020 07:50:52 -0500 

Thx 

FDA-OC_FOl_2020-6423_001014