2020-12-02 00:55:13 UTC: i (b)(G) i Messages-> 

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

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

To: Mark Meadows [·-·-·-·-·-·-·-·-·-·-jii)(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 01 Dec 2020 19:55:13 -0500 

, ____ wtu~_.!?J!Yl119Jl:!.~1.Y9-!J._~~~w.~rnn.~~~_u~'5~[1__t9.Jh~._w.9_qg_§t:t~Q-~~•--_QY.~Ltb_~ . ..R~9.~_.9tEUA approval -l __________ (l?.H~L. ______ J 

L·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· (b )( 5) -·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·___: 

FDA-OC_FOl_2020-6423_003092 
2020-12-02 00:56:14 UTC: i (b)(G) i Messages-> 

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

From: Mark Meadows [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Tue, 01 Dec 2020 19:56:14 -0500 

I will call John. Totally made up 

FDA-OC_FOl_2020-6423_003093 
2020-12-02 00:58:24 UTC: i (b)(G) i Messages-> 

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

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

To: Mark Meadows [·-·-·-·-·-·-·-·-·-·-jii)(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 01 Dec 2020 19:58:24 -0500 

Thx 

FDA-OC_FOl_2020-6423_003094 
2020-12-02 10:13:52 UTC: i (b)(G) i Messages-> 

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

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

To: Mark Meadows [·-·-·-·-·-·-·-·-·-·-jii)(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Wed, 02 Dec 2020 05:13:52 -0500 

FYI, we received notice that the UK will issue a temporary authorization of the Pfizer vaccine 

FDA-OC_FOl_2020-6423_003095 
2020-12-02 11 :07:48 UTC: i (b)(G) i Messages-> 

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

From: Mark Meadows [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Wed, 02 Dec 2020 06:07:48 -0500 

FDA-OC_FOl_2020-6423_003096 
2020-12-02 11 :08:55 UTC: i (b)(G) i Messages-> 

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

From: Mark Meadows [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Wed, 02 Dec 2020 06:08:55 -0500 

Please have you and peter marks come to my office today please 

FDA-OC_FOl_2020-6423_003097 
2020-12-02 12:10:46 UTC: i (b)(G) i Messages-> 

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

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

To: Mark Meadows [·-·-·-·-·-·-·-·-·-·-jii)(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Wed, 02 Dec 2020 07:10:46 -0500 

___ _Tbe.\l.rec.ehl.edJhe.ir_manuf.acturfon.data.na.ckaae_ort.M.ondav_aruUf L _________________________________________________ _(_b.)15_L_______________________________________ i 

i (b )( 5) [" _______ , 

i-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-i 

FDA-OC_FOl_2020-6423_003098 
2020-12-02 12:10:58 UTC: i (b)(G) i Messages-> 

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

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

To: Mark Meadows [·-·-·-·-·-·-·-·-·-·-jii)(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Wed, 02 Dec 2020 07:10:58 -0500 

And yes we will come to your office 

FDA-OC_FOl_2020-6423_003099 
2020-12-02 12:32:04 UTC: i (b)(G) i Messages-> 

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

From: Mark Meadows [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Wed, 02 Dec 2020 07:32:04 -0500 

So the UK is approving it and i _________________________________________________ J b ){ 5 ) ___________________________________________________ ! 

FDA-OC_FOl_2020-6423_003100 
2020-12-02 12:38:13 UTC: i (b)(G) i Messages-> 

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

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

To: Mark Meadows [·-·-·-·-·-·-·-·-·-·-jii)(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Wed, 02 Dec 2020 07:38:13 -0500 

i (b)(5) ! 

L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·· 

FDA-OC_FOl_2020-6423_003101 
2020-12-02 12:38:14 UTC: i (b)(G) i Messages-> 

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

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

To: Mark Meadows [·-·-·-·-·-·-·-·-·-·-jii)(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Wed, 02 Dec 2020 07:38:14 -0500 

https://www.google.com/amp/s/mobile.reuters.com/article/amp/idUKKBN28C1 B9 

FDA-OC_FOl_2020-6423_003102 
2020-12-02 12:40:19 UTC: i (b)(G) i Messages-> 

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

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

To: Mark Meadows [·-·-·-·-·-·-·-·-·-·-jii)(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Wed, 02 Dec 2020 07:40:19 -0500 

. ·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·1 

! i 

I (b)(S) I 

( _______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ i 

FDA-OC_FOl_2020-6423_003105 
2020-12-02 12:45:07 UTC: i (b)(G) i Messages-> 

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

From: Mark Meadows [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Wed, 02 Dec 2020 07:45:07 -0500 

l-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ( b )( 5_) -·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· l 

FDA-OC_FOl_2020-6423_003106 
2020-12-02 12:59:34 UTC: i (b)(G) i Messages-> 

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

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

To: Mark Meadows [·-·-·-·-·-·-·-·-·-·-jii)(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Wed, 02 Dec 2020 07:59:34 -0500 

I {b){S) I 

j_-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-•-• I 

FDA-OC_FOl_2020-6423_003107 
2020-12-02 13:01 :05 UTC: i (b)(G) i Messages -> 

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

From: Mark Meadows [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Wed, 02 Dec 2020 08:01 :05 -0500 

r·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·1 

i i 

I (b)(5) I 

!·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·! 

FDA-OC_FOl_2020-6423_003108 
2020-12-02 14:50:53 UTC: i (b)(G) i Messages-> 

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

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

To: Mark Meadows [·-·-·-·-·-·-·-·-·-·-jii)(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Wed, 02 Dec 2020 09:50:53 -0500 

I (b)(S) I 

i.·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

FDA-OC_FOl_2020-6423_003109 
2020-12-02 14:52:59 UTC: i (b)(G) i Messages-> 

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

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

To: Mark Meadows [·-·-·-·-·-·-·-·-·-·-jii)(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Wed, 02 Dec 2020 09:52:59 -0500 

·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·~ ' i ' i 

I (b)(5) I 

t·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·l 

FDA-OC_FOl_2020-6423_003110 
2020-12-02 14:58:20 UTC: i (b)(G) i Messages-> 

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

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

To: Mark Meadows [·-·-·-·-·-·-·-·-·-·-jii)(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Wed, 02 Dec 2020 09:58:20 -0500 

l·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· (_b )( 5) ·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-___i 

FDA-OC_FOl_2020-6423_003111 
2020-12-10 23:27:11 UTC: i (b)(G) i Messages-> 

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

From: Mark Meadows [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Thu, 10 Dec 2020 18:27:11 -0500 

Give me a call 

FDA-OC_FOl_2020-6423_003112 
2020-12-11 01 :14:41 UTC: i (b)(G) i Messages-> 

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

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

To: Mark Meadows [·-·-·-·-·-·-·-·-·-·-jii)(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Thu, 10 Dec 2020 20:14:41 -0500 

I called 

FDA-OC_FOl_2020-6423_003113 
2020-12-11 01 :52:20 UTC: i (b)(G) i Messages-> 

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

From: 

To: 

Date: 

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

Mark Meadows [·-·-·-·-·-·-·-·-·-·-jii)(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Thu, 10 Dec 2020 20:52:20 -0500 

We met after VRBPAC and we made the decision to move forward with the EUA. Teams working in shifts to get the 

needed work done. We told the sponsor and given them the ok to preposition vaccine at clinical sites now. Vaccine can 

be administered after EUA issued. Redfield and CDC notified and they are coordinating with OWS. We've also notified 

OWS of the decision to move forward. 

FDA-OC_FOl_2020-6423_003114 
2020-12-11 01 :57:02 UTC: i (b)(G) i Messages-> 

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

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

To: Mark Meadows [·-·-·-·-·-·-·-·-·-·-jii)(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Thu, 10 Dec 2020 20:57:02 -0500 

We are issuing a proactive statement subject to comms clearance from HHS and WH 

FDA-OC_FOl_2020-6423_003115 
2020-12-11 12:59:42 UTC: i (b)(G) i Messages-> 

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

From: Mark Meadows [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Fri, 11 Dec 2020 07:59:42 -0500 

Give me a call 

FDA-OC_FOl_2020-6423_003116 
2020-12-11 17:13:25 UTC: i (b)(G) i Messages-> 

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

From: Mark Meadows [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Fri, 11 Dec 2020 12:13:25 -0500 

Call me 

FDA-OC_FOl_2020-6423_003117 
2020-12-11 19:20:51 UTC: i (b)(G) i Messages-> 

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

From: Mark Meadows [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Fri, 11 Dec 2020 14:20:51 -0500 

Call me please 

FDA-OC_FOl_2020-6423_003118 
2020-12-16 14:51 :16 UTC: i (b)(G) i Messages-> 

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

From: Mark Meadows [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Wed, 16 Dec 2020 09:51:16-0500 

Call me 

FDA-OC_FOl_2020-6423_003119 
2020-12-16 15:07:46 UTC: i (b)(G) i Messages -> 

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

From: Mark Meadows [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Wed, 16 Dec 2020 10:07:46 -0500 

! _______________ ( b) ( 4), __ ( b )_( 6) _______________ i 

FDA-OC_FOl_2020-6423_003120 
2020-12-16 15:07:50 UTC: i (b)(G) i Messages -> 

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

From: Mark Meadows [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Wed, 16 Dec 2020 10:07:50 -0500 

Thanks 

FDA-OC_FOl_2020-6423_003121 
2020-12-16 15:16:58 UTC: i (b)(G) i Messages-> 

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

From: Mark Meadows [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Wed, 16 Dec 2020 10:16:58 -0500 

Thanks for handling 

FDA-OC_FOl_2020-6423_003122 
2020-12-16 15:18:21 UTC: i (b)(G) i Messages-> 

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

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

To: Mark Meadows [·-·-·-·-·-·-·-·-·-·-jii)(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Wed, 16 Dec 2020 10:18:21 -0500 

Thank you. Talked ttj (b)(4)i and am connecting him directly to the team. Gave him my cell so that he could contact me 

directly L--·-·-·-·-' 

FDA-OC_FOl_2020-6423_003123 
2020-12-16 23:55:01 UTC: i (b)(G) i Messages-> 

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

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

To: Mark Meadows [·-·-·-·-·-·-·-·-·-·-jii)(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Wed, 16 Dec 2020 18:55:01 -0500 

We just issued an EUA. __ .I.here_are_s9me additional issues for more masks that need to be worked out with the company 

and we are doing tha(_ _____ jb)(4) _______ iaware and thankful. Spoke to him just now. I will personally hold their hands 

through this. Whoever is contacting you, PLEASE have them contact me directly and I will take care of issues myself. 

FDA-OC_FOl_2020-6423_003124 
2020-12-16 23:58:19 UTC: i (b)(G) i Messages-> 

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

From: Mark Meadows [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Wed, 16 Dec 2020 18:58:19 -0500 

Thanks Doc 

FDA-OC_FOl_2020-6423_003125 
2020-12-16 23:58:42 UTC: i (b)(G) i Messages-> 

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

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

To: Mark Meadows [·-·-·-·-·-·-·-·-·-·-jii)(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Wed, 16 Dec 2020 18:58:42 -0500 

If they have ANY concerns I address them right away 

FDA-OC_FOl_2020-6423_003126 
2020-12-16 23:58:53 UTC: i (b)(G) i Messages-> 

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

From: Mark Meadows [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Wed, 16 Dec 2020 18:58:53 -0500 

Thanks so much 

FDA-OC_FOl_2020-6423_003127 
2020-12-17 19:33:41 UTC: i (b)(G) i Messages-> 

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

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

To: Mark Meadows [·-·-·-·-·-·-·-·-·-·-jii)(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Thu, 17 Dec 2020 14:33:41 -0500 

Update: we're making good progress with i (b)(4) Ion the additional issues. Been on the phone with them 4 times 

today. They owe us some information and 'rvifasl<ea·them to lean on their team to get it to us. We have a clear path 

forward. 

FDA-OC_FOl_2020-6423_003128 
2020-12-18 01 :16:12 UTC: i (b)(G) i Messages-> 

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

From: 

To: 

Date: 

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

Mark Meadows [·-·-·-·-·-·-·-·-·-·-jii)(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Thu, 17 Dec 2020 20:16:12 -0500 

I wanted to let you know that we have informed Moderna that we will rapidly work toward finalization and issuance of an 

emergency use authorization. Our teams are working to finalize the EUA now and we're on track for tomorrow. We have 

notified the CDC and OWS, so they can execute their plans 

FDA-OC_FOl_2020-6423_003129 
2020-12-18 01 :17:28 UTC: i (b)(G) i Messages-> 

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

From: Mark Meadows [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

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

Date: Thu, 17 Dec 2020 20:17:28 -0500 

Thanks 

FDA-OC_FOl_2020-6423_003130 
2020-10-02 00:29:11 UTC: i (b)(G) i Messages-> 

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

From: Stacy Amin :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

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

Date: Thu, 01 Oct 2020 20:29:11 -0400 

https://mobile.twitter.com/Jennifer JJacobs/status/1311820562587619333 

FDA-OC_FOl_2020-6423_003131 
2020-10-02 00:48:33 UTC: i (b)(G) i Messages-> 

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

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

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

Date: Thu, 01 Oct 2020 20:48:33 -0400 

Makes more sense. 

FDA-OC_FOl_2020-6423_003133 
2020-10-02 11 :27:52 UTC: i (b)(G) i Messages -> 

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

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

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

Date: Fri, 02 Oct 2020 07:27:52 -0400 

Guess it was even more serious. 

FDA-OC_FOl_2020-6423_003134 
2020-11-25 20:55:23 UTC: i (b)(G) i Messages-> 

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

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

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

Date: Wed, 25 Nov 2020 15:55:23 -0500 

I received this 6 page letter at my apartment today 

FDA-OC_FOl_2020-6423_003135 
2020-11-25 21 :54:12 UTC: i (b)(G) i Messages-> 

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

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

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

Date: Wed, 25 Nov 2020 16:54:12 -0500 

FDA-OC_FOl_2020-6423_003137 
2020-12-02 10:14:31 UTC: i (b)(G) i Messages-> 

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

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

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

Date: Wed, 02 Dec 2020 05:14:31 -0500 

Can we speak about ______________________________ (_b )_( 5) _________________________________ ~ 

FDA-OC_FOl_2020-6423_003139 
2020-12-12 15:04:49 UTC: i (b)(G) i Messages-> 

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

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

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

Date: Sat, 12 Dec 2020 10:04:49 -0500 

I'm guessing the WH leaked this yesterday to bolster Meadows. It's quite a game. 

FDA-OC_FOl_2020-6423_003140 
2020-04-24 20:14:01 UTC: i (b)(G) i Messages-> 

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

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

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

Date: Fri, 24 Apr 2020 16:14:01 -0400 

POTUS needs me at WH now 

FDA-OC_FOl_2020-6423_003670 
2020-05-05 22:05:58 UTC: i (b)(G) i Messages-> 

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

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

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

Date: Tue, 05 May 2020 18:05:58 -0400 

Navarro wants to chat with you. 

FDA-OC_FOl_2020-6423_003672 
2020-05-05 22:06:05 UTC: i (b)(G) i Messages-> 

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

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

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

Date: Tue, 05 May 2020 18:06:05 -0400 

About HCQ 

FDA-OC_FOl_2020-6423_003673 
2020-05-05 22:06:24 UTC: i (b)(G) i Messages-> 

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

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

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

Date: Tue, 05 May 2020 18:06:24 -0400 

Would you like to speak with him this evening or tomorrow am before Joe call? 

FDA-OC _FOl_2020-6423_00367 4 
2020-05-12 17:27:08 UTC: i (b)(G) i Messages-> 

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

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

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

Date: Tue, 12 May 2020 13:27:08 -0400 

You know you are presenting o~ _____ __(_b)(S) ___ ___ion WHTF agenda today? 

FDA-OC_FOl_2020-6423_003675 
2020-05-15 00:00:09 UTC: i (b)(G) i Messages-> 

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

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

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

Date: Thu, 14 May 2020 20:00:09 -0400 

WH wants you there by 11 :15/11 :30 to get tested. In the process of trying to changei (b )(5) i Will be in touch 

when I have an update. '-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·' 

FDA-OC_FOl_2020-6423_003676 
2020-05-15 00:01 :55 UTC: i (b)(G) i Messages-> 

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

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

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

Date: Thu, 14 May 2020 20:01 :55 -0400 

Okthx 

FDA-OC_FOl_2020-6423_003677 
2020-05-15 00:02:47 UTC: i (b)(G) i Messages-> 

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

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

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

Date: Thu, 14 May 2020 20:02:47 -0400 

Don't change. I'll go to WH earlier and get tested 

FDA-OC_FOl_2020-6423_003678 
2020-05-19 17:37:22 UTC: i (b)(G) i Messages-> 

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

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

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

Date: Tue, 19 May 2020 13:37:22 -0400 

Did you speak with Curative CEO Fred Barnes yesterday? Just need to close loop with Mango. 

FDA-OC_FOl_2020-6423_003679 
2020-05-19 17:38:04 UTC: i (b)(G) i Messages-> 

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

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

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

Date: Tue, 19 May 2020 13:38:04 -0400 

This is th~ (b)(4) iguy? j_ ____________ • 

FDA-OC_FOl_2020-6423_003680 
2020-05-19 17:38:37 UTC: i (b)(G) i Messages -> 

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

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

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

Date: Tue, 19 May 2020 13:38:37 -0400 

Thought it was l_ _______________________________________ (b )( 4) -·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-___! 

FDA-OC_FOl_2020-6423_003681 
2020-05-19 17:38:54 UTC: i (b)(G) i Messages-> 

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

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

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

Date: Tue, 19 May 2020 13:38:54 -0400 

[ _______________________________ ___( b) ( 5) _________________________________ i 

FDA-OC_FOl_2020-6423_003682 
2020-05-19 17:39:24 UTC: i (b)(G) i Messages-> 

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

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

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

Date: Tue, 19 May 2020 13:39:24 -0400 

Oh right. Yes I did and I told the secretary yesterday 

FDA-OC_FOl_2020-6423_003683 
2020-05-28 00:21 :15 UTC: i (b)(G) i Messages-> 

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

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

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

Date: Wed, 27 May 2020 20:21 :15 -0400 

WHTF interferes with CD meeting and Gates call. Want me to try and reschedule both? 

FDA-OC_FOl_2020-6423_003684 
2020-06-11 16:29:39 UTC: i (b)(G) i Messages-> 

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

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

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

Date: Thu, 11 Jun 2020 12:29:39 -0400 

' i ' i 

I (b)(5) I 

i..·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-j 

FDA-OC_FOl_2020-6423_003685 
2020-06-11 16:30:07 UTC: i (b)(G) i Messages-> 

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

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

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

Date: Thu, 11 Jun 2020 12:30:07 -0400 

,·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·. 

I __________________________________________________ J_~_)_(_~l __________________________________________________ I 

FDA-OC_FOl_2020-6423_003686 
2020-06-15 13:48:43 UTC: i (b)(G) i Messages-> 

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

From: 

To: 

Date: 

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

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

Mon, 15 Jun 2020 09:48:43 -0400 

From Peter - ,-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-, 

L~---Sorry~forth~b~(~:a_y,i__~--~--~--~--~--~--~--~--~-_J·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·J~)~~L-._·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·! 

The Mayo are a little behind with getting the analysis c!oo~.--b.~_t_a.re._:tra._osfe.crJog_11_s_t,_altgUbe._.re.m.ajoiog_s.a.mpJ.e.~JateL. ______ , _____ tod.av..and.balf.tomnrrow.Jn.mak.e.1m_a_bit_ov.P..r_s_oo.n. __ 1._ ____________________________________ ~-···-·-·-·-·-·-·-·-·-·~_(?.!(~L,-._·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_·_.! 

i (b)(S) but the database will still be getting cleaned and 

'-·Tocl<ecfaHliaf pofnc·wefai"Efalmfri~rto"f1avern1ifforlifaTarfaly"sl~fcompleted by COB Thursday of this week, and will do 

whatever we can to move this up if it does not mean sacrificing accuracy. 

FDA-OC_FOl_2020-6423_003687 
2020-06-15 13:53:41 UTC: i (b)(G) i Messages-> 

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

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

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

Date: Mon, 15 Jun 2020 09:53:41 -0400 

Thx 

FDA-OC_FOl_2020-6423_003688 
2020-06-15 14:25:01 UTC: i (b)(G) i Messages-> 

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

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

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

Date: Mon, 15 Jun 2020 10:25:01 -0400 

From Peter on Mccaul issue: 

r_.I.he.v_are_aojoa..to._caU_the.Jirm.to.da',{J&·~~f edul.e_.aJirn.eJoc.tomorrow...aod.to.JetJ.qen~ ~7if ~et~!lcvlcfdiscut~iri~-m-·-·-·-·-·-·-·-·-·J 

'-"fo"morrow:-·Tfie-"Offfce-is-"fiy1nglo-·move·~fs"fasras-irca"rC6uCne·easl6-fiave·-tffeir-fhoughts in clear order before speaking to 

the sponsor on substantive issues. 

FDA-OC_FOl_2020-6423_003689 
< 

Stephen:> 

No one is on 

I won't be joining 

Don't I have a 3JJm call? 

Delivered 

Q W E R T Y U 0 p 

A S D F G H J K L 

• Z X C V B N M 

space 

FDA-OC_FOl_2020-6423_003727 
2020-05-05 23:43:01 UTC: i ________________________________ (b)(G) _____________________________ ___i Messages -> [3 

recipients] 

From: Stacy Amin :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Anand Shah [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Keagan Lenihan [·-·-·-·-·-·-·-·-·-·-jii)(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 05 May 2020 19:43:01 -0400 

l·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ( b) ( 5) -·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-i 

FDA-OC_FOl_2020-6423_004040 
2020-05-05 23: 43: 54 U TC: ! ________________________________ ( b )( s ) ________________________________ ! Messages -> [3 

recipients] 

From: Anand Shah [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Stacy Amin [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Keagan Lenihan [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 05 May 2020 19:43:54 -0400 

r·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-, 

Ok good to know. I also mentioned to Mangol_ ________ (b)(5) ______ ___! 

FDA-OC_FOl_2020-6423_004041 
2020-05-05 23:58:01 UTC: i ________________________________ (b)(G) _____________________________ ___i Messages -> [3 

recipients] 

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

To: Stacy Amin [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Anand Shah [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Keagan Lenihan [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 05 May 2020 19:58:01 -0400 

[ _________ ( b )_( 5 ) __________ ! 

FDA-OC_FOl_2020-6423_004042 
2020-05-06 00: 06: 57 UTC: ! ________________________________ (b )(G) ________________________________ i Messages -> [3 

recipients] 

From: Stacy Amin :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Anand Shah [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Keagan Lenihan [·-·-·-·-·-·-·-·-·-·-jii)(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 05 May 2020 20:06:57 -0400 

I {b)(5) I 

i.·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

FDA-OC_FOl_2020-6423_004043 
2020-05-06 00: 07: 12 UTC: ! ________________________________ (b )(G) ________________________________ i Messages -> [3 

recipients] 

From: Stacy Amin :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Anand Shah [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Keagan Lenihan [·-·-·-·-·-·-·-·-·-·-jii)(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 05 May 2020 20:07:12 -0400 

I ________________________ ( b) ( 5) _______________________ ! 

FDA-OC_FOl_2020-6423_004044 
2020-05-06 00: 08: 15 UTC: ! ________________________________ (b )(G) ________________________________ i Messages -> [3 

recipients] 

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

To: Stacy Amin [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Anand Shah [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Keagan Lenihan [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 05 May 2020 20:08: 15 -0400 

! ___________________________________ { b_) {_5 ) ___________________________________ I 

FDA-OC_FOl_2020-6423_004045 
2020-05-06 00: 09: 38 UTC: ! ________________________________ (b )(G) ________________________________ i Messages -> [3 

recipients] 

From: Anand Shah [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Stacy Amin [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Keagan Lenihan [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 05 May 2020 20:09:38 -0400 

Stact _______________________________________________________ ( b) ( 5) ·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·! 

FDA-OC_FOl_2020-6423_004046 
2020-05-06 00: 10:44 UTC: i ________________________________ (b)(G) ________________________________ i Messages -> [3 

recipients] 

From: Anand Shah [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Stacy Amin [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Keagan Lenihan [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 05 May 2020 20: 10:44 -0400 

i-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ( b) ( 5 )·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· I 

FDA-OC _FOl_2020-6423_00404 7 
2020-05-06 00: 11 : 26 UT C: [ _____________________________ ___( b )( s ) ________________________________ ! Messages -> [3 

recipients] 

From: Keagan Lenihan [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Stacy Amin [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Anand Shah [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 05 May 2020 20: 11 :26 -0400 

ThxAnand. 

FDA-OC_FOl_2020-6423_004048 
2020-05-06 00: 13: 06 UTC: ! ________________________________ (b )(G) ________________________________ i Messages -> [3 

recipients] 

From: Stacy Amin :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Anand Shah [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Keagan Lenihan [·-·-·-·-·-·-·-·-·-·-jii)(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 05 May 2020 20: 13:06 -0400 

i·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ( b) ( 5 )·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· I 

FDA-OC_FOl_2020-6423_004049 
2020-05-06 00: 13:20 UTC: i ________________________________ (b)(G) ________________________________ i Messages -> [3 

recipients] 

From: Stacy Amin :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Anand Shah [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Keagan Lenihan [·-·-·-·-·-·-·-·-·-·-jii)(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 05 May 2020 20: 13:20 -0400 

[ _____________________________________________ ( b )_ ( 5) ---------------------------------------------! 

FDA-OC_FOl_2020-6423_004050 
2020-05-06 00: 13: 57 UTC: ! ________________________________ (b )(G) ________________________________ i Messages -> [3 

recipients] 

From: Keagan Lenihan [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Stacy Amin [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Anand Shah [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 05 May 2020 20: 13:57 -0400 

i (b)(5) i 

··-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-) 

FDA-OC_FOl_2020-6423_004051 
2020-05-06 00: 14: 15 UTC: i ________________________________ (b)(G) ________________________________ i Messages -> [3 

recipients] 

From: Anand Shah [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Stacy Amin [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Keagan Lenihan [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 05 May 2020 20:14:15 -0400 

! _________________ ( b_) (_5) _______________ ! 

FDA-OC_FOl_2020-6423_004052 
2020-05-06 00: 14: 33 U TC: ! ________________________________ ( b )( s ) ________________________________ ! Messages -> [3 

recipients] 

From: Stacy Amin :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Anand Shah [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Keagan Lenihan [·-·-·-·-·-·-·-·-·-·-jii)(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 05 May 2020 20:14:33 -0400 

L__·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ( b )( 5) ·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-___! 

FDA-OC_FOl_2020-6423_004053 
2020-05-06 00: 14: 41 U TC: ! ________________________________ ( b )( s ) ________________________________ ! Messages -> [3 

recipients] 

From: Keagan Lenihan [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Stacy Amin [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Anand Shah [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 05 May 2020 20:14:41 -0400 

[ ______________________ ( b) (5 ) _______________________ ] 

FDA-OC_FOl_2020-6423_004054 
2020-05-06 00: 14: 52 U TC: ! ________________________________ ( b )( s ) ________________________________ ! Messages -> [3 

recipients] 

From: Keagan Lenihan [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Stacy Amin [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Anand Shah [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 05 May 2020 20:14:52 -0400 

[ ________________________________ ( b )_( 5) _______________________________ ] 

FDA-OC_FOl_2020-6423_004055 
2020-05-06 00: 15:00 UTC: i ________________________________ (b)(G) ________________________________ i Messages -> [3 

recipients] 

From: Anand Shah [·-·-·-·-·-·-·-·-·-·-jiij(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Stacy Amin [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Keagan Lenihan [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 05 May 2020 20: 15:00 -0400 

Yes 

FDA-OC_FOl_2020-6423_004056 
2020-05-06 00: 15:35 UTC: i ________________________________ (b)(G) ________________________________ i Messages -> [3 

recipients] 

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

To: Stacy Amin [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Anand Shah [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Keagan Lenihan [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 05 May 2020 20: 15:35 -0400 

l _________________________________ ( b )( 5) -·-·-·-·-·-·-·-·-·-·-·-·-·-·-·___! 

FDA-OC_FOl_2020-6423_004057 
2020-05-06 00: 23: 28 U TC: ! ________________________________ ( b )( s ) ________________________________ ! Messages -> [3 

recipients] 

From: Stacy Amin :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Anand Shah [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Keagan Lenihan [·-·-·-·-·-·-·-·-·-·-jii)(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 05 May 2020 20:23:28 -0400 

i ______________________________________________________________________ ( b) ( 5 ) ______________________________________________________________________ i 

FDA-OC_FOl_2020-6423_004058 
2020-05-06 01 :05:02 UTC: i ________________________________ (b)(G) _____________________________ ___i Messages -> [3 

recipients] 

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

To: Stacy Amin [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Anand Shah [·:.·:.·:.·:.·:.·:.·:.·:.·:3~i(sf.·:.·:.·:.·:.·:.·:.·:.·:.·J messages">, Keagan Lenihan [·-·-·-·-·-·-·-·-·-·-jii}(sY-·-·-·-·-·-·-·-·-·-·1 messages"> 

Date: Tue, 05 May 2020 21 :05:02 -0400 

[ _____________ ( b )( 5) ____________ _! 

FDA-OC_FOl_2020-6423_004059 
2020-06-26 14:03:42 UTC: i (b)(G) i Messages-> 

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

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

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

Date: Fri, 26 Jun 2020 10:03:42 -0400 

This SH is ok OWS meeting. 

FDA-OC_FOl_2020-6423_004295 
2020-06-26 14:03:54 UTC: i (b)(G) i Messages-> 

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

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

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

Date: Fri, 26 Jun 2020 10:03:54 -0400 

Then right to WHTF and presser. Is it urgent? 

FDA-OC_FOl_2020-6423_004296 
2020-06-26 14:04:22 UTC: i (b)(G) i Messages-> 

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

From: Stacy Amin :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

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

Date: Fri, 26 Jun 2020 10:04:22 -0400 

On LDTs. In case it's raised in TF. 

FDA-OC_FOl_2020-6423_004297 
2020-07-08 19:30:32 UTC: i (b)(G) i Messages-> 

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

From: Stacy Amin :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

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

Date: Wed, 08 Jul 2020 15:30:32 -0400 

In case you don't have Twitter (which I do not....) I saw this in a news article. Just sending as an FYSA. 

FDA-OC_FOl_2020-6423_004298 
2020-07-08 19:31 :57 UTC: i (b)(G) i Messages-> 

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

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

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

Date: Wed, 08 Jul 2020 15:31 :57 -0400 

POTUS going after CDC today. 

FDA-OC_FOl_2020-6423_004300 
2020-07-08 19:32:03 UTC: i (b)(G) i Messages-> 

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

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

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

Date: Wed, 08 Jul 2020 15:32:03 -0400 

Will send the tweet about us. 

FDA-OC_FOl_2020-6423_004301 
2020-07-08 19:33:15 UTC: i (b)(G) i Messages-> 

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

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

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

Date: Wed, 08 Jul 2020 15:33:15 -0400 

FDA-OC_FOl_2020-6423_004302 
2020-07-29 12:57:12 UTC: i (b)(G) i Messages-> 

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

From: Stacy Amin :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

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

Date: Wed, 29 Jul 2020 08:57:12 -0400 

___ Steve •. I'm _sorrv I forgot to_ follow _up last night _that_Peter's. meetina this_morninq_is fine __________________________ (b )(5) ·-·-·-·-·-·-·-·-·-·-·-·-·_i __________ _ 

i-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-{ b) {_5 )·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· I 

FDA-OC_FOl_2020-6423_004304 
2020-07-29 12:59:41 UTC: i (b)(G) i Messages-> 

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

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

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

Date: Wed, 29 Jul 2020 08:59:41 -0400 

r-· l __ had _a _discussion_ with .Peter. last_n.Laht_ too _that_if the_ d/~fi~rsion_today_turns td ·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· (b )(5) ·-·-·-·-·-·-·-·-·-·-·-·-r---·-·-·-·-·! 

. (b)(5) ·-·-·! ··-·-·-·-~·-·-·,·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·· 

FDA-OC_FOl_2020-6423_004305 
2020-08-22 23:04:13 UTC: i (b)(G) i Messages-> 

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

From: Stacy Amin :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

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

Date: Sat, 22 Aug 2020 19:04:13 -0400 

OCC has just cleared the EUA documents---; (b)(G) i It was a tremendous amount of work yesterday, 

late into last night, and all day today. Great team"woi'l<-aiicfc6llaborafi6n with CBER and OCET. 

FDA-OC_FOl_2020-6423_004306 
2020-08-22 23:17:38 UTC: i (b)(G) i Messages-> 

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

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

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

Date: Sat, 22 Aug 2020 19:17:38 -0400 

Amazing!! Thank you, Stacy. Pis thank the team, absolutely amazing. Looks like it's turning into POTUS event tomorrow 

so that's exciting. 

FDA-OC_FOl_2020-6423_004307 
2020-10-01 19:49:16 UTC: i (b)(G) i Messages-> 

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

From: Stacy Amin :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

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

Date: Thu, 01 Oct 2020 15:49:16 -0400 

5 would be best for me if you can wait. 

FDA-OC_FOl_2020-6423_004308 
2020-10-01 19:49:30 UTC: i (b)(G) i Messages -> 

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

From: Stacy Amin :·-·-·-·-·-·-·-·-·-·-jii)(sY---·-·-·-·-·-·-·-·-·: messages"> 

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

Date: Thu, 01 Oct 2020 15:49:30 -0400 

I ___________________________________ (_ b) ( 5_) ________________________________ ___I 

FDA-OC_FOl_2020-6423_004309 
2020-12-24 19:23:18 UTC: i (b)(G) i Messages-> 

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

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

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

Date: Thu, 24 Dec 2020 14:23:18 -0500 

! . Hey .guysJ__ _____________________________________________ ( b) (: ;( 5) ___________________________________________________ __[: 

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

FDA-OC_FOl_2020-6423_004390 
2020-12-24 19:28:10 UTC: i (b)(G) i Messages-> 

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

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

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

Date: Thu, 24 Dec 2020 14:28:10 -0500 

Happy to check with the Center? 

FDA-OC_FOl_2020-6423_004391 
2020-12-24 19:29:42 UTC: i (b)(G) i Messages-> 

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

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

To: Stephen Hahn [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Thu, 24 Dec 2020 14:29:42 -0500 

t1~=~~i~-~-~1 OLP.ail ____________________________________ (b )( 5) _____ (b )( 5)---------------------------------------------- i i 

FDA-OC_FOl_2020-6423_004392 
2020-12-24 19:30:22 UTC: i (b)(G) i Messages-> 

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

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

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

Date: Thu, 24 Dec 2020 14:30:22 -0500 

Will do. Get back to you when I have info. 

FDA-OC_FOl_2020-6423_004393 
2020-12-24 19:33:43 UTC: i (b)(G) i Messages-> 

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

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

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

Date: Thu, 24 Dec 2020 14:33:43 -0500 

l·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-( b )_ ( 5) -·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·l 

FDA-OC_FOl_2020-6423_004394 
2020-12-24 19:58:35 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: Paul Mango [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Thu, 24 Dec 2020 14:58:35 -0500 

Thx Keagan 

FDA-OC_FOl_2020-6423_004395 
2020-12-24 19:58:46 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: Paul Mango [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Thu, 24 Dec 2020 14:58:46-0500 

Paul 

This is now online 

FDA-OC_FOl_2020-6423_004396 
2020-12-24 19:58:49 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: Paul Mango [:::::::::j~i(sf::::::::J messages">, Keagan Lenihan [·:.·:.·:.·:.·:.·:.·:.·:.·:3~5tsf_·:.·:.·:.·:.·:.·:.·:.·:.·J messages"> 

Date: Thu, 24 Dec 2020 14:58:49-0500 

https://www.fda.gov/media/144412/download 

FDA-OC_FOl_2020-6423_004397 
2020-12-24 20:00:17 UTC: i (b)(G) i Messages-> 

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

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

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

Date: Thu, 24 Dec 2020 15:00:17 -0500 

Peter says: We understand this - that is why the new physician labeling says a€reup to 6 dosesa€• and not 6 doses. We 

wanted to provide the flexibility to use what was available. That said - we are hearing that most locations are getting 6 

doses out of the vials. 

FDA-OC_FOl_2020-6423_004400 
2020-12-24 20:00:29 UTC: i (b)(G) i Messages-> 

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

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

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

Date: Thu, 24 Dec 2020 15:00:29-0500 

!-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·J~)_(_~)__ ____________________________________________________________________________________________________________ ___i 

FDA-OC_FOl_2020-6423_004401