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From: Smith, Michael (CBER)
Sent: Thursday, July 15, 2021 1:47 PM
To: Harkins Tull, Elisa <[email protected]>; Aghajani Memar, Neda
<[email protected]>; Devlin, Carmel M <[email protected]>
Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura
<[email protected]>
Subject: STN 125742.0: IR RE Study C4591007
Elisa,
The review team has the question below for you regarding Study C4591007. The
review team has requested that a response be submitted to the BLA by July 21, 2021.
We note that the goal dates provided for Study C4591007 final protocol
submission reflect the date of the first version of the protocol, which did not include all children 11 years of age and younger. Please provide updated goal dates for final protocol submission (that will include participants down to birth),
study completion and report submission for Study C4591007.
Regards,
Mike
- Please confirm receipt of this e -mail and let us know if you have any
questions.
Mike Smith, Ph.D.
Captain, USPHS
Senior Regulatory Review Officer
Food and Drug Administration
Center for Biologics Evaluation & Research
Office of Vaccines Research & Review
Division of Vaccines and Related Products Applications Tel: 301- 796-2640
[email protected]
FDA-CBER-2021-5683-1024693
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hone.
FDA-CBER-2021-5683-1024694