Record of Telephone Conversation - Cervarix, August 27, 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:  27-AUG-2009 10:09 AM              Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):

Other

Author:  HELEN GEMIGNANI

Telecon Summary:

Response to FDA Request for Information

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No    

Related STNs:  None

Related PMCs:  None

Telecon Body:

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From: Edward.M.Yuhas@gsk.com [mailto:Edward.M.Yuhas@gsk.com]
Sent: Thursday, August 27, 2009 10:09 AM
To: Gemignani, Helen S
Subject: Cervarix; Response to FDA Request for Information

Helen,
At the request of Matt Whitman, I have attached an excel file to this email that contains the PID numbers/treatment regimens associated with the information contained in Table 13 (as referenced in your email communications to M. Whitman dated August 25, 2009).
If you need any additional information regarding this data or have any difficulty in opening the file, please let me know (215-751-3836).
Regards