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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Sponsor calls, October 27, 2010 - MenHibrix

Date:
 
October 27, 2010
From:
 
David C. Staten, Jr., MPH, CDR, USPHS
Subject:
 
Sponsor call - October 22, 2010 Reference October 15 th email to sponsor
FDA call – October 25, 2010
To:
 
Administrative File STN 125363

Summary:

In the above referenced email FDA advised GSK to submit free-PC data on experiments performed to IND (b)(4) in order to review. The sponsor called and asked if the data could be submitted to the CR since they plan to submit the CR within a week. This request was surprising since FDA believes that GSK needs more development to address the free-PC in the vaccine. The Chair and I called GSK to discuss their planned submission. FDA conveyed that testing performed thus far will not be sufficient to address the CR questions. If GSK proceeds with their submission without further development, FDA will issue another CR