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Vaccines

Record of Telephone Conversation - Cervarix, October 9, 2009

System Info - 107653  SHONE, DEANNA   14-Oct-2009 13:23:13  SHONEDE

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:  09-OCT-2009 12:17 PM                Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):

Other

Author:  LORI AUSTIN-HANSBERRY

Telecon Summary:

GSK Accepts PMC Sample Size

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No  

Related STNs:  None

Related PMCs:  None

Telecon Body:


 

From: nicholas.perombelon@gskbio.com [mailto:nicholas.perombelon@gskbio.com]
Sent: Friday, October 09, 2009 12:17 PM
To: Austin-Hansberry, Lori
Cc: Cynthia.A.D'Ambrosio@gsk.com; Matt.Whitman@gsk.com; Gemignani, Helen S; Nguyen, Michael D.
Subject: Re: Cervarix - PMC Request for Clarification
Dear Lori,

Thank you for your reply and explanation for the sample size. GSK accepts this proposal for, at minimum, a cumulative total of 135,000 doses of Cervarix administered.

Best regards,

Nicholas