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Vaccines, Blood & Biologics

Homogeneity Testing - Cervarix, October 3, 2007

To: Mr. Matt Whitman
From: Helen S. Gemignani
File: STN 125259/0 CERVARIX
RE: Homogeneity Testing
Date: October 3, 2007

We note that in your amendment to the BLA dated September 28, 2007, you state that you conducted homogeneity testing for odds-ratios across studies using the Breslow-Day method (Final Integrated Analysis Report, Page 29). In our memo dated
September 4, 2007, we had requested that you provide an analysis for testing the homogeneity of relative risks among the studies in your Level 2 analysis. We continue to request that you provide the homogeneity test of relative risks. Please respond.

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