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Vaccines, Blood & Biologics

Record of Email Communication, October 30, 2009 - MenHibrix

Submission Type: BLA     Submission ID: 125363/0    Office: OVRR

Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate

GlaxoSmithKline Biologicals

Telecon Date/Time: 30-Oct-2009 12:00 PM         Initiated by FDA? No
Telephone Number:

Communication Category(s):
1. Information Request


Telecon Summary:
Information provided by GSK that was requested in the Oct. 21, 2009 telecon.

FDA Participants: Jason Humbert

Non-FDA Participants: Dr. Jody Gould, GSK

Telecon Body:
The following information was provided by GSK via e-mail as a preliminary response to the Oct. 21 information request. If the information provided is acceptable, GSK will submit this formally to the BLA.


17 pages determined to be not releasable (b)(4)

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