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Vaccines, Blood & Biologics
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.
Alan E. Williams, Ph.D.
Associate Director for Regulatory Affairs
Acting Chief, Regulatory Project
Office of Blood Research and Review
Center for Biologics