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dgras0007

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dgras0007

Re: Chimaera post# 2363

Wednesday, 03/21/2012 12:15:05 PM

Wednesday, March 21, 2012 12:15:05 PM

Post# of 6072
No it wasn't. The 2 abstains count as "no's" so the decision is a 7-6 like I had predicted. So in a case like this it is almost solely up to the FDA to decide and guess what FDA will focus on confirmatory trials because of the size of the trials are too small currently. So I am issuing my recommendation which is a CRL for an additional trial.
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