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Cervarix - July 26 Clinical Comments - August 08, 2007

From: Sullivan, Helen M
To: "Matt.Whitman@gsk.com";
Subject: RE: Cervarix - July 26 Clinical Comments
Date: Wednesday, August 08, 2007 5:37:25 PM
Please submit updated safety reports until this time. CBER may request additional submissions of safety reports during the course of review of the BLA.

From: Matt.Whitman@gsk.com [mailto:Matt.Whitman@gsk.com] Sent: Thursday, July 26, 2007 4:33 PM To: Sullivan, Helen M Subject: Re: Cervarix - July 26 Clinical Comments
Hi Helen,
Can we please get the following clarification for Question 2:
Do you want these IND safety reports through Sept 30, 2006 (the BLA cut-off date for HPV-009)?
Thanks, Matt
"Sullivan, Helen M" <helen.sullivan@fda.hhs.gov>
To Matt.Whitman@gsk.com 26-Jul-2007 13:32 cc Subject Cervarix - July 26 Clinical Comments
Please find attached additional clinical comments from CBER.
<<07 26 07 EM clinical.pdf>> [attachment "07 26 07 EM clinical.pdf" deleted by Matt Whitman-1/SB-OTHER/PHRD/ SB_PLC]
"EMF <fda.hhs.gov>" made the following annotations.
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