Record of Telephone Conversation-Cervarix, August 9, 2007

Record of Telephone Conversation

STN Number: 125259/0
Manufacturer: GlaxoSmithKline Biologicals
Product: Human Papillomavirus Vaccine, ASO4 Adjuvant-Adsorbed

To: File
From: Helen S. Gemignani, Regulatory Project Manager
Subject: MPL Safety Analysis Plan Statistical Discussion
Telecon Date: August 9, 2007 Telecon Time: 11:30 am – 12:00 pm
Telecon Initiated by: GSK
Contact Phone: 610 787-3726 Mr. Whitman
 Signature:

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Summary of Telecon

As a follow up to this morning's telecon (9-10 AM), this 11:30 am telecon discussed the details of the statistical analysis plan and how to analyze the combined data from all studies for products that have MPL. Dr. Lee clarified the issues of a weighted, fixed effect, true meta-analysis. GSK's statisticians were in agreement. GSK and CBER were in agreement and this issue of analysis has been resolved.

GSK indicated that the CBER recommendation for a true meta-analysis will not impact on the timelines that they proposed for submission of data from their clinical studies for products that include MPL.

End of Teleconference

Action Items

• GSK will perform a true meta-analysis and submit to CBER by August 27, 2007.   

FDA Participants

• Gopa Raychaudhuri
• Nancy Miller
• Martha Lee
• Amelia Dale Horne
• Helen Gemignani

GSK Participants

• Amy Scott
• Vince Ahonkai
• Matt Whitman
• Gary Dubin
• Brigitte Cheuvart
• Fabian Tibaldi
• Marie-Pierre David