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