Record of Telephone Conversation - Cervarix, August 28, 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: 28-AUG-2009 11:21 AM Initiated by FDA? Yes
Author: HELEN GEMIGNANI
Response to FDA Question
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Edward.M.Yuhas@gsk.com [mailto:Edward.M.Yuhas@gsk.com]
Sent: Friday, August 28, 2009 11:21 AM
To: Gemignani, Helen S
Subject: Cervarix: Response to FDA Question
At the request of Matt Whitman, I have attached an excel file that contains the information requested in your 26 Aug 2009 email. In that email you requested the following regarding Tables 18 and 19 of the FDA briefing document; 1) PIDs (and associated GSK case numbers) for the cases presented in the "n" column of supplement 273 for each non-vaccine HPV type (by treatment group); and 2) a list of PIDs (and associated GSK case numbers) for the additional cases included in the "n" column of Supplement 199 for each non-vaccine HPV type (by treatment group).
If you need any additional information regarding this data, please email me or phone me at 215-751-3836.