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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, December 8, 2011 - Flublok

 

Submission Type: BLA    Submission ID: 125285/0    Office: OVRR
Product:
Influenza Vaccine
Applicant:
Protein Sciences Corporation
Telecon Date/Time: 08-Dec-2011 10:40 AM        Initiated by FDA? Yes
Telephone Number:
Communication Categorie(s):
1. Information Request
 
Author: TIMOTHY FRITZ
Telecon Summary:
--b(4)--------- data and Nov 10, 2011 telecon info.
FDA Participants: Timothy Fritz
Non-FDA Participants: Penny Post
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Telecon Body:
Dr. Post was called and asked to provide a revised figure of –b(4)----------------- data for   -b(4)-----------------------. Protein Sciences Corporation (PSC) had indicated in their September 16, 2011 submission (Amendment 47) that this figure would be provided when available. PSC was also asked to provide the corresponding –b(4)------------- figure for Sf9 cells. PSC said that they would request the figures from –b(4)-----------------------------------------. PSC was also reminded to submit the material provided via e-mail on November 10, 2011 for a telecon on the same day as an amendment to the BLA.