
Record of Telephone Conversation, April 8, 2011 - Spherusol

 

 
Submission Type: BLA    Submission ID: 125354/0    Office: OVRR

Product:

Coccidioides immitis Spherule-Derived Skin Test Antigen

Applicant:

Allermed Laboratories, Inc.

Telecon Date/Time: 08-Apr-2011 02:30 PM        Initiated by FDA? Yes

Telephone Number: 858-292-1060

Communication Categorie(s):

1. Information Request

 

Author: JON DAUGHERTY

Telecon Summary:

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

Telecon Body:



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.