Document text
From: Gottschalk, Laura
Sent: Thursday, July 22, 2021 8:52 PM
To: Harkins Tull, Elisa <[email protected]>
Cc: Naik, Ramachandra <[email protected]>; Smith, Michael (CBER)
<[email protected]>; Devlin, Carmel M <[email protected]>; Aghajani Memar, Neda
<[email protected]>
Subject: STN 125742/0: IR regarding clinical shell tables for study C4591001
Dear Ms. Harkins,
Reference is made to your original BLA STN 125742/0. Attached, please find CBER’s information request
regarding clinical shell tables for study C4591001. As noted in the document, please provide your
responses in an amendment to STN 125742/0 by COB Monday, July 26, 2021.
Please confirm receipt of this email and let me know if you have any questions or need additional information.
Best regards,
Laura
Laura Gottschalk, PhD
Regulatory Project Manager/Primary Revie wer
Center for Biologics Evaluation and Research
Office of Vaccines Research and Review
U.S. Food and Drug Administration
Tel: 301 -796- 0798
[email protected]
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FDA-CBER-2021-5683-1024696