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Vaccines

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

Product:

Influenza Vaccine

Applicant:

Novartis Vaccines and Diagnostics, Inc.

Telecon Date/Time: 23-Nov-2009 11:25 AM        Initiated by FDA? Yes

Telephone Number: 617-460-2376

Communication Categorie(s):

1. Advice

Author: BERNARD MCWATTERS

Telecon Summary:

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

Telecon Body:

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.