Submission Type: BLA Submission ID: 125354/0 Office: OVRR
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Vaccines, Blood & Biologics
Coccidioides immitis Spherule-Derived Skin Test Antigen
Allermed Laboratories, Inc.
Telecon Date/Time: 08-Apr-2011 02:30 PM Initiated by FDA? Yes
Telephone Number: 858-292-1060
1. Information Request
Author: JON DAUGHERTY
Requested information on product lot(s), Clinical Study 104-1 and NDC numbers.
FDA Participants: JON DAUGHERTY, SHELDON MORRIS
Non-FDA Participants: MICHAEL DURSCHLAG
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
We called Allermed discuss the following items. Dr. Nielsen was not available, so we spoke with Mr. Michael Durschlag.
Product lots(s): Mr. Durschlag said that Allermed is preparing a new lot of skin test antigen, and that the testing of the lot should be completed by the end of --(b)(4)--.
Clinical Study 104-1: We requested that Allermed reanalyze the data from that study without including the two subjects that reacted to the control. Mr. Durschlag will relay this request to Dr. Nielsen.
NDC number(s): Mr. Durschlag stated that Allermed had received advice on the procedure for requesting NDC numbers, but it found the advice to be unclear. We offered to help Allermed obtain the information in a form that will be clearer.