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Vaccines

Record of Telephone Conversation - Cervarix, August 28, 2009

RECORD OF TELEPHONE CONVERSATION

Submission Type: Original Application   Submission ID:  125259/0    Office: OVRR  

Product:

Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant

Applicant:                                                                        

GlaxoSmithKline Biologicals          

Telecon Date/Time:  28-AUG-2009 11:21 AM              Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):

Information Request

Author:  HELEN GEMIGNANI

Telecon Summary:

Response to FDA Question

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No     

Related STNs:  None

Related PMCs:  None

Telecon Body:


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

Helen,
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.
Regards