Record of Telephone Conversation - Cervarix, August 27, 2009
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: 27-AUG-2009 10:09 AM Initiated by FDA? Yes
Author: HELEN GEMIGNANI
Response to FDA Request for Information
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Edward.M.Yuhas@gsk.com [mailto:Edward.M.Yuhas@gsk.com]
Sent: Thursday, August 27, 2009 10:09 AM
To: Gemignani, Helen S
Subject: Cervarix; Response to FDA Request for Information
At the request of Matt Whitman, I have attached an excel file to this email that contains the PID numbers/treatment regimens associated with the information contained in Table 13 (as referenced in your email communications to M. Whitman dated August 25, 2009).
If you need any additional information regarding this data or have any difficulty in opening the file, please let me know (215-751-3836).