Record of Telephone Conversation - Cervarix, Sept 30, 2009

System Info - 106070  SHONE, DEANNA   28-Sep-2009 14:58:33  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:  24-SEP-2009 10:18 AM                Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):

Other

Author:  HELEN GEMIGNANI

Telecon Summary:

Agreement to PMR

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:

---

 

From: nicholas.perombelon@gskbio.com [mailto:nicholas.perombelon@gskbio.com]
Sent: Thursday, September 24, 2009 10:18 AM
To: Gemignani, Helen S
Cc: Cynthia.A.D'Ambrosio@gsk.com; Matt.Whitman@gsk.com
Subject: Re: Cervarix - Commitment

Dear Helen,
GSK agrees to the timings set out in the email below for the analytic epidemiological study to assess the risk of spontaneous abortions.
We understand that study completion will be the completion of all assessments for the final analysis. We propose that the definition of study completion be included in the final approved study protocol.
Thanks and best regards,
Nicholas