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Cervarix - Question RE Oct 11 submission, October 12, 2007

From: Sullivan, Helen M
To: "Sharon.W.Shapowal@gsk.com";
CC: "Matt.Whitman@gsk.com";
Subject: Cervarix - Question RE: Oct 11 submission
Date: Friday, October 12, 2007 2:25:22 PM

In the material sent in the 10/11/07 amendment for BLA 125259, the treatment assignment for subject PID 1098 in Study 013 does not appear to match what was provided in the subject datasets. Could you ask the blinded statistician to recheck this. Thank you.

Helen Sullivan Gemignani Regulatory Project Manager FDA/CBER/OVRR Division of Vaccines and Related Products Applications/Viral Vaccine Branch
(301) 827-3070