Record of Telephone Conversation - Cervarix, July 14, 2009
System Info - 99584 SHONE, DEANNA 15-Jul-2009 15:11:16 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: 14-JUL-2009 05:43 PM Initiated by FDA? Yes
Author: HELEN GEMIGNANI
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Gemignani, Helen S
Sent: Tuesday, July 14, 2009 5:43 PM
To: 'Matt.Whitman@gsk.com'; 'Cynthia.A.D'Ambrosio@gsk.com'; 'firstname.lastname@example.org'
We spoke to Cynthia last week in regard to PSURs. CBER would like the PSURs from March 2009 and May 2009 to be submitted to the BLA.