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Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation - Cervarix, August 11, 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:  11-AUG-2009 11:59 AM              Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):

Information Request

Author:  HELEN GEMIGNANI

Telecon Summary:

Follow-up Information Request RE: HPV-008 - FDA TC

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:


From: Matt.Whitman@gsk.com [mailto:Matt.Whitman@gsk.com]
Sent: Tuesday, August 11, 2009 11:59 AM
To: Gemignani, Helen S; Levis, Robin
Cc: Cynthia.A.D'Ambrosio@gsk.com; nicholas.perombelon@gskbio.com
Subject: Fw: Follow-up Information request re: HPV-008 - FDA TC

Hi Helen - here is the requested table for Martha Lee and Nancy Miller. I hope this is the information they needed. Please pass this along and let me know if they need any further information. Thanks Matt.
Please find also source document (this document contains all 14 oncogenic HPV types + HRW & HR and contains complete information)