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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information Request Email, April 11, 2011 - Anascorp

Our STN: 125335/0

Company: Rare Disease Therapeutics, Inc.
Attention: Ms. Jennifer Spinells
Date: April 11, 2011
By email
 
Dear Ms. Spinella:
 
We are reviewing your resubmission to your biologics license application for Centruroides (Scorpion) Immune F(ab)2 Intravenous (Equine).  We determined that the following information is necessary to continue our review:
 
  1. Please resubmit all three SAS.xpt files to include Study ID in each file.
 
The review of this submission is on-going and issues may be added, expanded upon, or modified as we continue to review this submission. Please submit your response to this information request as an amendment to this file by April 18, 2011. If you anticipate you will not be able to respond by this date, please contact the Agency immediately so a new response date can be identified.
 
If we determine that your response to this information request constitutes a major amendment, we will notify you in writing. 
 
The action due date for this file is August 3, 2011.
 
If you have any questions, please contact me at (301)827-6157.
 
Sincerely,
 
 
 

Debbie Cordaro
Regulatory Project Manager
FDA/CBER/OBRR