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Vaccines, Blood & Biologics

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Vaccines

Telecon - GSK Cervarix, August 14, 2007

From: Baylor, Norman
To: Raychaudhuri, Gopa; Miller, Nancy; Levis, Robin; Sullivan, Helen M;
CC: McVittie, Loris; Gruber, Marion; Toerner, Joseph (CBER);
Subject: Telecon: GSK Cervarix
Date: Tuesday, August 14, 2007 11:25:20 AM


I spoke to Dr. Matt Whitman (Dr. Ahonkhai was on leave) at GSK this morning at
11:10 am. I informed Dr. Whitman that our current plan is to take Cervarix to the VRBPAC on 12 December 2007; however, depending on the outcome of our review of the MPL safety data, this meeting may have to be rescheduled. I also requested that GSK be prepared to present an overview of the manufacture of MPL and provide a description of the cell substrate used in the manufacture of Cervarix in open session. Dr. Whitman stated that he would inform the GSK Cervarix team and management