Record of Telephone Conversation, December 5, 2012 - BAT
Submission Type: BLA Submission ID: 125462/0 Office: OBRR
Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) (Equine)
Telecon Date/Time: 05-Dec-2012 09:46 AM Initiated by FDA? No
1. Information Request
Author: ROBERT FISHER
Request for clarification on: 1) ownership of donor horse herd; 2) responsibility for immunization program; 3) quality agreements related to questions 1 and 2.
FDA Participants: None
Non-FDA Participants: None
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Requested clarification on the horse herd used as a plasma source for the production of HBAT (aka NP-018, eBAT, BAT). Asked Cangene to provide details on 1) the ownership of donor horse herd (Cangene or USG); 2) responsibility for immunization program (currently performed by Auburn University personnel); 3) quality agreements related to questions 1 and 2.