Submission Type: BLA Submission ID: 125363/0 Office: OVRR
Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate
Telecon Date/Time: 30-Oct-2009 12:00 PM Initiated by FDA? No
1. Information Request
Author: JASON HUMBERT
Information provided by GSK that was requested in the Oct. 21, 2009 telecon.
FDA Participants: Jason Humbert
Non-FDA Participants: Dr. Jody Gould, GSK
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)