Record of Telephone Conversation - Cervarix, May 4, 2007

Record of Telephone Conversation
 STN Number: 125259/0
 Manufacturer: GSK
 Product: Human Papillomavirus Vaccine, AS04 Adjuvant-Adsorbed (CERVARIX)
 To: File
 From: Helen S. Gemignani, Regulatory Project Manager
 Subject: Priority Review Request
 Telecon Date: 04-May-2007 Telecon Time: 11:50AM
 Telecon Initiated by: Helen S. Gemignani
 Contact Phone: 610 787-3763
 Signature:
 Summary of Telecon
 I left Sharon Shapowal a voicemail that the Cervarix™ Review Committee and OVRR management discussed GSK's request for Priority Review and it was determined, by OVRR management, that Cervarix™ will be reviewed under a 10 month standard review clock and that documentation of this decision will be included in the Filing Letter.
 End of Teleconference
 Action Items
• Include 10 month standard review language in the Filing Letter
 FDA Participants
• Helen S. Gemignani
 Non-FDA Participants
• Sharon Shapowal