(System Info - 112478 MCWATTERS BERNARD 12/01/2009 16:30:28 MCWATTERS)
RECORD OF TELEPHONE CONVERSATION
Submission Type: BLA Submission ID: 125297/0 Office: OVRR
Applicant: Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 24-Nov-2009 10:00 AM
Initiated by FDA? Yes
Telephone Number: (617) 460-2376
Author: BERNARD MCWATTERS
Telecon Summary: Advised Novartis that we would need a PMC to do a non-inferiority study with US licensed comparitor in adults 50 years and up.
FDA Participants: Melisse Baylor, Bernard McWatters
Non-FDA Participants: Joanne Totosy de Zepetnek, Hillel Cohen
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
After internal discussions with the clinical reviewers it was determined that a non-inferiority immunogenicity study would be needed comparing AGRIFLU to a US licensed trivalent vaccine. We also told Novartis that we needed this commitment before licensure and they would need to submit approximate dates with a month and a year when the protocol would be submitted, when the study would start and when the final study report would be submitted. Novartis agreed to submit this as an amendment to the BLA.