System Info - 94743 SHONE, DEANNA 20-May-2009 17:40:01 SHONEDE
RECORD OF TELEPHONE CONVERSATION
Submission Type: Original Application Submission ID: 125259/0 Office: OVRR
Human Papillomavirus Vaccine, AS04 Adjuvant-Adsorbed
Telecon Date/Time: 20-DEC-2007 12:00 AM Initiated by FDA? Yes
Author: NORMAN BAYLOR
CR Letter: discussion of addressing the major CR letter issues and request for telecon with CBER.
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Baylor, Norman
Sent: Thu 12/20/2007 1:14 PM
To: Clare.Kahn@gsk.com; Houn, Florence
Cc: Barbara.J.Howe@gsk.com; Penney, Melissa
Subject: RE: Suitable time for short TC on Cervarix CR Letter
I would like to follow-up on one point from our discussion this morning. I understood you to say that you were comfortable with providing us safety updates on SAEs reported as possibly related to Cervarix through 30 September 2007. We selected the September timeframe because this was 1 year beyond the 30 September 2006 data lock poiint, and 3 months out from the issuance of our CR letter. Now, however, since GSK's response to our CR letter may be several months out, I want to clarify that we would like an updated table of events as close to the date of your response to the 14 December 2007 CR letter as possible. Further, I should also state that we will need an additional update of these events close to the timing of the VRBPAC meeting, as yet to be scheduled. Please acknowledge that you agree to providing us with this information as per the timelines I have proposed. Thanks.