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Vaccines

Record of Telephone Conversation - Cervarix, October 2, 2009

System Info - 107035  SHONE, DEANNA   06-Oct-2009 16:56:29  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:  02-OCT-2009 07:01 PM                Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):

Information Request

Author:  HELEN GEMIGNANI

Telecon Summary:

PMC - Submission of Final Clinical Study Report Dates

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:


 

From: Gemignani, Helen S
Sent: Friday, October 02, 2009 7:01 PM
To: 'nicholas.perombelon@gskbio.com'
Cc: 'Matt.Whitman@gsk.com'; 'Cynthia.A.D'Ambrosio@gsk.com'
Subject: Cervarix - PMC - Submission of Final Clinical Study Report Dates

CBER will ask you to commit to submit final Clinical Study Reports for long term efficacy studies 008, 009, 023, 024, 015 and 040 when completed.

 

Please provide the following dates for each study:

  • Final protocol submission to the IND
  • Completion of subject accrual
  • Study Completion
  • Projected submission of final Clinical Study Report

 

Helen Sullivan Gemignani
Regulatory Project Manager
FDA/CBER/OVRR
Division of Vaccines and 
Related Products Applications/Viral Vaccine Branch
(301) 827-3070