
Resubmission Confirmation Letter - Anascorp

 
 

Our STN: BL 125335/0

 

Rare Disease Therapeutics, Inc.

Attention: Mr. Milton H Ellis

2550 Meridian Boulevard, Suite 150

Franklin, TN 37067

 

Dear Mr. Ellis:

 

We have received your January 31, 2011 resubmission to your biologics license application for Centruroides (Scorpion) Immune F(ab)2 Intravenous (Equine) on February 1, 2011.

 

The resubmission contains your responses to our July 23, 2009 complete response letter. 

 

We consider this a complete, Class 2 response to our action letter. Therefore, the user fee goal date is August 3, 2011.

 

If you have any questions, please contact the Regulatory Project Manager, Debra Cordaro, at 301-827-6157.

 

Sincerely yours,

 

 

 

Alan E. Williams, Ph.D.

Associate Director for Regulatory Affairs

Acting Chief, Regulatory Project

 Management Branch

Office of Blood Research and Review

Center for Biologics