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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Telecon - GSK Cervarix, December 06, 2007

From: Baylor, Norman 

To:  Levis, Robin; Sullivan, Helen M; Miller,Nancy;

CC:  McVittie, Loris; Houn, Florence; 

Subject:  Telecon: GSK Cervarix

Date: Thursday, December 06, 2007 6:40:41 PM

I spoke to Drs. Vincent Ahonkai and Sharon Shapowal this evening at 5:45 pm. They wanted an update on where the Agency is on the review of Cervarix. I stated that the review team has noted several concerns from their evaluation of the data that need to be addressed by GSK. I told them that we were drafting a CR letter and intended to issue the letter this month. I further told them that once they receive the letter and digest the contents, we would invite them in or have a teleconference to discuss the issues outlined in the letter, and provide any clarifications needed. Dr. Ahonkai asked if they could have their experts participate in the meeting, and whether CBER would have experts participate. I responded that we had no objections to their experts participating; however, at this time, I did not know whether we would have external experts participate. I did tell them that we have sought external consultation from an expert to review some of the data. Dr. Ahonkai asked me whether we had to disclose the CR letter, and I responded that we do not; however, I commented that surely they are aware of the disclosure requirements on their end. He responded that they would be having this discussion, i.e., disclosure requirements, with the senior management in GSK.