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Vaccines, Blood & Biologics

Response to FDA Question of October 12, 2007 - Cervarix, October 26, 2007

From: Edward.M.Yuhas@gsk.com
To: Sullivan, Helen M;
Subject: Cervarix; Response to FDA Question of Oct 12, 2007
Date: Friday, October 26, 2007 7:24:05 PM

Helen, Reference is made to your email communication to Sharon Shapowal dated 12 Oct 2007 requesting clarification of the treatment received by patient 1098 (see below). I have been informed that this patient received HPV vaccine. A formal submission of this information to the BLA will occur shortly. Regards

"Sullivan, Helen M" helen.sullivan@fda.hhs.gov
 

To  Sharon.W.Shapowal@gsk.com
cc  Matt.Whitman@gsk.com
Subject  Cervarix - Question RE: Oct 11 submission

12-Oct-2007 14:25
 


Sharon,
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 re-check this. Thank you.
Helen
"EMF <fda.hhs.gov>" made the following annotations.
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