Document text
From: Mineo, Gosia
Sent: Tuesday, April 26, 2022 4:14 PM
To: Smith, Michael (CBER) <[email protected]>
Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura
<[email protected]>; MaguireThon, Meghan <[email protected]>;
Harkins Tull, Elisa <Elisa.HarkinsT [email protected]>; Devlin, Carmel M <[email protected]>;
Collins, Kathleen Mary Catherin e
Subject: RE: [EXTERNAL] RE: STN 125742/45 & IND 19736: IR RE request for a revised study protocol for
Study C4591022 - pregnancy registry study (postmarketing commitment (PMC) #10 as described in the STN 125742/0 approval letter)
CAUTION: This email originated from outside of the organizatio n. Do not click links or open attachments unless you
recognize the sender and know the content is safe.
Thank you very much, Mike. Yes, I confirm we will provide the response by May 6
th, likely sooner.
Thank you and kind regards, Gosia
From: Smith, Michael (CBER) < [email protected] >
Sent: Tuesday, April 26, 2022 3:35 PM
To: Mineo, Gosia
Cc: Naik, Ramachandra < Ra [email protected] >; Gottschalk, Laura
<[email protected] >; MaguireThon, Meghan < [email protected] >;
Harkins Tull, Elisa < [email protected] >; Devlin, Carmel M < [email protected] >;
Collins, Kathleen Mary Catherine
Subject: RE: [EXT ERNAL ] RE: STN 125742/45 & IND 19736: IR RE request for a revised study protocol for
Study C4591022 - pregnancy registry study (postmarketing commitment (PMC) #10 as described in the
STN 125742/0 approval letter)
Gosia,
Pfizer’s proposal to submit the revised protocol and SAP to IND 19736 by May 20
th is
acceptable. However, please submit an IR response to STN 125742.45 by May 6th
(sooner if possible) confirming your intention to revise the pregnancy registry study protocol and SAP to include pregnant individuals of all ages. Regards, Mike
From: Mineo, Gosia
Sent: Tuesday, April 26, 2022 2:08 PM
To
: Smith, Michael (CBER) < [email protected] > Michael J.
Smith -S4Digitally signed by Michael J. Smith -S4 Date: 2022.04.26 16:22:07 -04'00'
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FDA-CBER-2022-5812-0500402
Cc: Naik, Ramachandra < [email protected] >; Gottschalk, Laura
<[email protected] >; MaguireThon, Meghan < [email protected] >;
Harkins Tull, Elisa < [email protected] >; Devlin, Carmel M < [email protected] >;
Collins, Kathleen Mary Catherine
Subject: [EXT ERNAL] RE: STN 125742/45 & IND 19736: IR RE request for a revised study protocol for
Study C4591022 - pregnancy registry study (postmarketing commitment (PMC) #10 as described in the
STN 125742/0 approval letter)
CAUTION: This email originated from outside of the organizatio n. Do not click links or open attachments unless you
recognize the sender and know the content is safe.
Hi Mike –
In the below communication, you requested we submit the revised final study Protocol and SAP for C4591022 to IND 19736 by May 6, 2022.
Unfortunately, it will take some time to turn around these documents and thus we won’t be able to meet this date. We can submit the protocol and SAP amendments on May 20. Would this please be
acceptable? Thank you, Gosia
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FDA-CBER-2022-5812-0500403