
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.