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Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation - Cervarix, October 7, 2009 with Attachment

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:  07-OCT-2009 12:22 PM                Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):

Other

Author:  HELEN GEMIGNANI

Telecon Summary:

Response to Clinical IR

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: N    

Related STNs:  None

Related PMCs:  None

Telecon Body:


From: nicholas.perombelon@gskbio.com [mailto:nicholas.perombelon@gskbio.com]
Sent: Wednesday, October 07, 2009 12:22 PM
To: Gemignani, Helen S
Cc: Cynthia.A.D'Ambrosio@gsk.com; Matt.Whitman@gsk.com
Subject: Re: Cervarix - PMC - Submission of Final Clinical Study Report Dates

Dear Helen,
GSK agrees to commit to submitting the final clinical study reports for the long-term efficacy studies listed in your mail. Please find in the attachment the timings we would propose for the submission of these reports, except for HPV-009. As you know, HPV-009 is under NCI supervision, therefore we are checking with them before committing to timings for this study. We expect to have the details for HPV-009 tomorrow.
If you have any questions on the other studies, please don't hesitate to ask.
Thanks and best regards,

Nicholas

 

Attachment - Timings for Efficacy Studies