Vaccines, Blood & Biologics
Record of Telephone Conversation, July 13, 2011 - Spherusol
Submission Type: BLA Submission ID: 125354/0 Office: OVRR
Coccidioides immitis Spherule-Derived Skin Test Antigen
Allermed Laboratories, Inc.
Telecon Date/Time: 13-Jul-2011 06:10 PM Initiated by FDA? Yes
Telephone Number: 858-292-1060
1. Information Request
Author: JON DAUGHERTY
Lot release protocols and product samples requested
FDA Participants: Jon R. Daugherty, Ph.D.
Non-FDA Participants: H.S Nielsen Jr., Ph.D.
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
The applicant was notified that the revised version of the lot release protocol received on July 6, 2011, is acceptable. The applicant was asked to submit copies of the final release protocols and samples to the CBER sample custodian as described in our June 24, 2011 facsimile to Allermed. I mentioned that any questions regarding submission of samples can be addressed to Mr. Joe Quander III per our facsimile of June 24, 2011.