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Vaccines, Blood & Biologics

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Question for Fibrocell Email, May 12, 2011 - Laviv

From: Tull, Lori
  Sent: Thursday, May 12, 2011 8:50 AM
  To: 'Dana Weinberger'
  Subject: RE: Question for Fibrocell

Thank you!

Lori A. Tull, RAC
  Regulatory Project Manager
  Office of Cellular, Tissue, and Gene Therapies
  Center for Biologics Evaluation and Research
  (301) 827-5359
  THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS ADDRESSED   AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM   DISCLOSURE UNDER LAW. If you are not the addressee, or a person authorized to   deliver the document to the addressee, you are hereby notified that any review,   disclosure, dissemination, copying, or other action based on the content of this   communication is not authorized. If you have received this document in error,   please immediately notify the sender immediately by e-mail or phone.

From: Dana Weinberger [mailto:dweinberger@cbrintl.com]
  Sent: Wednesday, May 11, 2011 10:11 PM
  To: Tull, Lori
  Cc: Jeanne Novak; Dana Weinberger
  Subject: FW: Question for Fibrocell
 

Dear Lori,
 
  Across all six studies described in Table 2 of Amendment 39, there was a total   of 158 subjects treated.  IT-G-003 was a follow-on study, in which 12 of the 20   subjects from IT-G-002 were enrolled.  Also, IT-H-001 enrolled 16 subjects who   previously participated in IT-A-008.  (Note: the other 13 subjects in IT-H-001   previously participated in IT-R-005 and IT-R-006, not discussed in the table.)   The difference between 186 and 158, 28, is accounted for by the sum of the 12   subjects who participated in both IT-G-002 and IT-G-003, and the 16 subjects who   participated in both IT-A-008 and IT-H-001.
 
  We have reported the numbers consistently with this approach throughout   Amendment 39, so we do not feel that any revisions are required.  We hope that   this explanation is helpful.
 
  Please feel free to contact me or Jeanne Novak with any questions or requests.
 
  Thanks,
  Dana
 
  Dana A. Weinberger, Ph.D., RAC
  Director of Regulatory Affairs
  CBR International Corp.®
  2905 Wilderness Place Ste. 202
  Boulder, CO 80301
  (877)270-1345 - Nation-wide Toll Free
  720-746-1190 Office
  720-746-1192 Fax
  <A href="http://www.cbrintl.com www.cbrintl.com />  
  This electronic transmission (including any and all attachments) is intended   solely for the use of the individual or entity to whom it is addressed and may   contain information that is privileged and/or confidential. If you are not the   intended recipient of this electronic transmission, you are hereby notified that   any disclosure, copying or distribution, or the taking of any action in reliance   upon the contents of this electronic transmission, is strictly prohibited, and   you are further requested to purge this electronic transmission and all copies   thereof from your computer system.
 
  From: Tull, Lori [mailto:Lori.Tull@fda.hhs.gov]
  Sent: Wednesday, May 11, 2011 12:16 PM
  To: Jeanne Novak; Dana Weinberger
  Subject: FW: Question for Fibrocell
 
  Hi Jeanne and Dana,
 
  We have a question regarding Amendment 39 below.
 
  "For Amendment 39, page 5 of 16, Table 2, total number of subjects seems to be   186 instead of 158.  Please clarify this number and correct all calculation of AE in all the Tables that may be affected."

  Best Regards,
  Lori
  Lori A. Tull, RAC
  Regulatory Project Manager
  Office of Cellular, Tissue, and Gene Therapies
  Center for Biologics Evaluation and Research
  (301) 827-5359
  THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS ADDRESSED   AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM   DISCLOSURE UNDER LAW. If you are not the addressee, or a person authorized to   deliver the document to the addressee, you are hereby notified that any review,   disclosure, dissemination, copying, or other action based on the content of this   communication is not authorized. If you have received this document in error,   please immediately notify the sender immediately by e-mail or phone.