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Re: kheath39 post# 51960

Tuesday, 12/22/2015 4:54:03 PM

Tuesday, December 22, 2015 4:54:03 PM

Post# of 198910
yes, the de novo that was filed last last year failed, and the response from the fda was to resubmit with animal testing results. we're currently reading that the fda has not required human trials from AMIC/ADMD
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