Vaccines, Blood & Biologics
Resources for You
Record of Telephone Conversation, May 27, 2009 - Flublok
Submission Type: Original Application Submission ID: 125285/0 Office: OVRR
Protein Sciences Corporation
Telecon Date/Time: 27-MAY-2009 12:00N Initiated by FDA? Yes
2. Information Request
Author: KATHERINE MATRAKAS
Request information about the process validation study for 2009 runs for the H3 antigen. Conveyed CR responses were complete and letter pending.
FDA Participants: Rakesh Pandey, Tim Fritz, Kathy Matrakas
Non-FDA Participants: Manon Cox, Penny Post
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
CBER held a telecon with Protein Sciences (PSC) to inquire whether the data from the process validation study for 2009 runs for the H3 antigen was available. PSC indicated that they had completed the runs for 3 batches of H3 HA protein and could provide CBER with an interim report in mid June. Data for the validation run of the batches of H1 and B HA proteins would be provided to CBER at a later date. They also indicated that adventitious agent, mycoplasma and spiroplasma testing data would not be available for the mid June submission, which was acceptable to CBER. PSC also indicated that short range testing results would be available and included in the interim report to be submitted mid June. PSC indicated that data and reports are compiled as data becomes available.
CBER also indicated that it had determined that the sponsor’s responses to the August 29, 2008 CR letter received by CBER on April 28, 2009; have been considered to be complete and that a letter with the new action due date would be issued in a few days. We reiterated that CBER’s determination that PSC’s responses to the CR letter were complete did not imply that the responses were found to be adequate for approval and that another Complete Response Letter could be issued when the reviews are completed. The sponsor acknowledged that they knew and understood this.
Protein Sciences also indicated that their process validation runs would continue through June for the B strains and they would do b(4) HA runs that would finish around the end of August to the beginning of September 2009. CBER asked about the time period between formulation and filling ie., whether it was filled immediately or would take a day in between and the sponsor said they would have to investigate that further. Formulation would take place in July. We indicated that CBER would have further internal discussion regarding the dosage and how to formulate the product in order to provide any feedback for filling. CBER also indicated that there may be some clinical and statistical questions that would need some clarification and we may schedule a telecon about that in the near future.