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."
Lori A. Tull, RAC
Regulatory Project Manager
Office of Cellular, Tissue, and Gene Therapies
Center for Biologics Evaluation and Research
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