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Vaccines, Blood & Biologics

Stat Comments Response, August 12, 2007- Cervarix, August 22, 2007

From: Sullivan, Helen M
To: "";
CC: "";
Subject: RE: Cervarix BLA - 8/12/07 Stat Comments response
Date: Wednesday, August 22, 2007 12:14:04 PM

Amy, Our statistician has looked it over and agrees that you may proceed The statistical plan for meta-analysis is acceptable. Helen

From: [] Sent: Monday, August 20, 2007 6:32 PM To: Sullivan, Helen M Subject: Cervarix BLA - 8/12/07 Stat Comments response
Hi Helen,

Here is the response to the Aug 12 FDA statistical request and the mock-up table that was agreed at our teleconference on Aug 9. Since time is short until the Aug 27 submission of the meta-analysis results, I'm e-mailing these to you to provide to Martha and others as necessary.

Kind regards, Matt

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