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Summary Of Internal Meeting, June 29, 2010 - Spherusol

Date:                  June 29, 2010

 
File:                    BLA STN 125354/ Allermed Coccidioidin
 
Subject:              Adequacy of Response to March 26, 2010 CR Letter
                       
Prepared by:       Jon R. Daugherty, Ph. D.
                          CBER/OVRR/DVRPA/CMC1
 
 
On June 29, 2010, a meeting was scheduled to discuss the status of the BLA STN 125354. The primary focus of this meeting was to determine whether the May 28, 2010 responses of the sponsor to CBER’s complete response letter of March 26, 2010 wereadequate. The participants in the meeting included Sheldon Morris, Jon Daugherty, Wellington Sun, Ann Schwartz, Jingyee Kou, Paul Richman, Deb Trout, Karen Campbell, and Siobhan Cowley. After considerable discussion, the committee decided that the sponsor’s responses to CBER’s clinical, statistical, and product concerns were incomplete. Therefore, the committee concluded that CBER should send the sponsor a letter describing the incomplete items within his May 28 response which could not be adequately reviewed.