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Vaccines, Blood & Biologics

Record of Telephone Conversation - Cervarix, October 9, 2009

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


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


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


GlaxoSmithKline Biologicals          

Telecon Date/Time:  09-OCT-2009 12:17 PM                Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):



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: []
Sent: Friday, October 09, 2009 12:17 PM
To: Austin-Hansberry, Lori
Cc: Cynthia.A.D';; 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,


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