Record of Telephone Conversation, July 27, 2010 - Flublok
Submission Type: BLA Submission ID: 125285/0 Office: OVRR
Protein Sciences Corporation
Telecon Date/Time: 27-Jul-2010 11:00 AM Initiated by FDA? Yes
Telephone Number: (203) 599-6064 x156
Author: TIMOTHY FRITZ
June 29, 2010 CR letter response is incomplete.
Dr. Rakesh Pandey
Dr. Timothy Fritz
Dr. Penny Post
Drs Manon Cox
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
CBER informed PSC that PSC’s June 29, 2010 response to CBER’s January 11, 2010 CR Letter was incomplete and, thus, that the review clock has not yet restarted.
CBER stated that PSC’s response to comments #3-8 of CBER’s January 11, 2010 CR Letter were essentially complete and that the information CBER still required for CR Letter item #4 (--b(4)-------------------------------- analysis) would not be considered as incomplete.
CBER informed PSC that the following was still needed for a complete response:
- The final B manufacturing process validation report (CR Letter comment 1a)
- The validation report for H1 purification (CR Letter comment 1b)
- The stability data for Process Validation run #2 (CR Letter comment 1c)
- The results of the –b(4)---------- validation of the –b(4)--------------------------- used in the –b(4)-- assay for b(4) (CR Letter comment 2). PSC’s June 29, 2010 response suggested that PSC was planning to submit additional information from ---b(4)------- regarding validation of a –b(4)-- assay and that this information would be ready around mid August.
PSC said that the information for CR Letter items 1a and 1b may be submitted this week. PSC was surprised that CBER wanted the PV2 stability data in order to consider their response complete because PSC thought that CBER had told PSC in the April 12, 2010 face-to-face meeting that this information could be submitted during the review of their response. However, PSC indicated that this information should be ready soon. PSC asked if they submitted the information for CR Letter items 1a and 1b this week whether CBER would consider the response to be complete and consider the June 29, 2010 submission date to be the review start date. CBER said no.
PSC was very concerned about the b(4)issue and said that they were waiting for guidance from CBER regarding whether the path PSC was taking to resolve the b(4) issue was acceptable to CBER.
CBER also told PSC that it was concerned about PSC’s problem with their H1 potency assay and referred them to concerns expressed in Bill McCormick's email of June 21, 2010. CBER asked PSC if they had plans to address CBER’s concerns. PSC mentioned that they were doing a mouse immunogenicity study.