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Record of Telephone Conversation - Cervarix, October 2, 2009 with Attachments
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: 02-OCT-2009 05:05 PM Initiated by FDA? Yes
Author: HELEN GEMIGNANI
Postmarketing Comments Follow Up and Request for Additional Information
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: firstname.lastname@example.org [mailto:email@example.com]
Sent: Friday, October 02, 2009 5:05 PM
To: Gemignani, Helen S
Cc: Cynthia.A.D'Ambrosio@gsk.com; Matt.Whitman@gsk.com
Subject: RE: Cervarix - Postmarketing Comments Follow Up and Request for Additional Information
Please find attached our responses to the questions raised in your mail of September 30, 2009 and the earlier mail of September 16, 2009.
With respect to analyses of SAEs, timeframes for following the various events, and the suggestion to use self controls, GSK has requested further clarification from CBER in the responses and to this purpose we would be willing to have a teleconference call with you to allow us to reach an understanding as soon as possible.
We will also submit the response documents to the BLA.
Thanks and best regards,