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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information Request Email, February 9, 2011 - Anascorp

Our STN: 125335/0

Company: Rare Disease Therapeutics, Inc.
Attention: Ms. Jennifer Spinells
Date: February 9, 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. Response to Q77: the Clinical Study Report XE-C-12 (for AL-0307 Clinical Study) has xpt files lacking a define file.  The datafiles cannot be reviewed without it.  Please submit a define.pdf or define.xml.
 
  1. We are unable to locate the data for XE-ISS-12.  There is only the ISS report. Please explain.
 
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 February 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. A new action due date for this file will be determined following an initial review of the submission.
 
If you have any questions, please contact me at (301)827-6157.
 
Sincerely,
 
 
 

Debbie Cordaro
Regulatory Project Manager
FDA/CBER/OBRR