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Vaccines

Record of Telephone Conversation - Cervarix, Jul. 30, 2009

System Info - 102433  SHONE, DEANNA   17-Aug-2009 16:08:10  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:  30-JUL-2009 08:05 AM                Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):

Advice

Author:  HELEN GEMIGNANI

Telecon Summary:

PSURs

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:


From: Gemignani, Helen S
Sent: Thursday, July 30, 2009 8:05 AM
To: 'nicholas.perombelon@gskbio.com'
Cc: 'Cynthia.A.D'Ambrosio@gsk.com'; 'Matt.Whitman@gsk.com'
Subject: Re: PSURs

Thanks Nicholas. Yes, the 4th PSUR was the one we were expecting.
We will get back to you on the onset analysis and whether CBER would like you to submit.