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Stat Comments Response, August 12, 2007 - Cervarix, August 20, 2007

Gemignani, Helen S

Sent: Monday, August 20, 2007 6:32 PM
To: Gemignani, Helen S
Subject: Cervarix BLA - 8/12/07 Stat Comments response
Attachments: Mock-up Table1 FDA03AUG2007.doc; Aug 12 stat response.doc
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,
"EMF <fda.hhs.gov>" made the following annotations.
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