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Vaccines, Blood & Biologics

Question for Fibrocell Email, May 11, 201 - Laviv

From:        Tull, Lori
  Sent:          Wednesday, May 11, 2011 2:16 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  A. Tull, RAC
  Regulatory Project Manager
  Office of Cellular, Tissue, and Gene Therapies
  Center for Biologics Evaluation and Research
  (301) 827-5359
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