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Record of Telephone Conversation - Agriflu, November 23, 2009
(System Info - 112475 MCWATTERS BERNARD 12/01/2009 16:18:46 MCWATTERS)
RECORD OF TELEPHONE CONVERSATION
Submission Type: BLA Submission ID: 125297/0 Office: OVRR
Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 23-Nov-2009 11:25 AM Initiated by FDA? Yes
Telephone Number: 617-460-2376
Author: BERNARD MCWATTERS
Requested that Novartis committ to submit the results of their clinical trial V58P13 by the end of January 2010.
FDA Participants: Melisse Baylor, Bernard McWatters
Non-FDA Participants: Hillel Cohen and Joanne Totosy de Zepetnek
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
The purpose of this call was to get Novartis to set a completion date for their efficacy trial in adults ages 18-49 as part of their accelerated approval. After discussion they said that they could submit those results before the end of January 2010.