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Record of Telephone Conversation - Cervarix, April 14, 2008
System Info - 94742 SHONE, DEANNA 20-May-2009 17:37:33 SHONEDE
RECORD OF TELEPHONE CONVERSATION
Submission Type: Original Application Submission ID: 125259/0 Office: OVRR
Human Papillomavirus Vaccine, AS04 Adjuvant-Adsorbed
Telecon Date/Time: 14-APR-2008 12:00 AM Initiated by FDA? Yes
Author: HELEN GEMIGNANI
VRBPAC - The CR response has not been submitted in full as of this date and therefore Cervarix will not be able to be presented at a July 2008 VRBPAC.
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Gemignani, Helen S
Sent: Monday, April 14, 2008 6:02 PM
Cc: 'Sharon Shapowal (Sharon.W.Shapowal@gsk.com)'
Subject: VRBPAC Information
Sharon had inquired about the earliest VRBPAC date at which Cervarix could be presented. At this point, there would not be adequate time to review the complete response and prepare for a July VRBPAC. Upon submission of your complete response (late April as per our most recent communication) we can commence discussion about the next potential VRBPAC date when the Cervarix application can be presented.
Helen Sullivan Gemignani
Regulatory Project Manager
Division of Vaccines and Related Products Applications/Viral Vaccine Branch