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Record of Telephone Conversation - Cervarix, Jul. 30, 2009
System Info - 102433 SHONE, DEANNA 17-Aug-2009 16:08:10 SHONEDE
RECORD OF TELEPHONE CONVERSATION
Submission Type: Original Application Submission ID: 125259/0 Office: OVRR
Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant
Telecon Date/Time: 30-JUL-2009 08:05 AM Initiated by FDA? Yes
Author: HELEN GEMIGNANI
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Gemignani, Helen S
Sent: Thursday, July 30, 2009 8:05 AM
Cc: 'Cynthia.A.D'Ambrosio@gsk.com'; 'Matt.Whitman@gsk.com'
Subject: Re: PSURs
Thanks Nicholas. Yes, the 4th PSUR was the one we were expecting.
We will get back to you on the onset analysis and whether CBER would like you to submit.