Submission Type: BLA Submission ID: 125296/0 Office: OVRR
Product: Adenovirus Vaccine Live Oral Type 4 and Type 7
Applicant: Teva Women's Health, Inc.
Telecon Date/Time: 07-Feb-2011 03:26 PM Initiated by FDA? Yes
Communication Category: Other – PMC Concurrence
Author: HELEN GEMIGNANI
Telecon Summary: Teva proposes revised timelines for the PMCs and CBER concurs.
FDA Participants: Helen Gemignani
Non-FDA Participants: Valerie Mulligan
Ms. Mulligan concurred with the postmarketing commitments (PMCs) yet proposed alternative timeline dates for two of the PMCs sent to her on January 26, 2011. She stated that DoD could not be certain of the start date of their administration of the Adenovirus vaccine, assuming a March 2011 BLA 125296 approval. Therefore, Teva requested that the study/trial completion date for the SSP and the NHRC programs be extended from the March 31, 2012 date, proposed by CBER, to July 31, 2012. The final report submission date would be modified accordingly i.e. a final report submission date of January 31, 2013 instead of September 30, 2012, for both studies.
I consulted with the CBER epidemiology reviewer on the file and she concurred with the proposed revised dates. I called Ms. Mulligan to inform her that CBER does concur with their proposed revised timelines and that those dates will be reflected in the final Action Letter.