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wimuskyfisherman

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wimuskyfisherman

Re: Samsa post# 16661

Friday, 07/15/2016 11:08:59 AM

Friday, July 15, 2016 11:08:59 AM

Post# of 38634
Samsa- The panel you talk about that will determine if the data supports bioequivalence or not- and in effect whether or not a PH3 is required. When do you think this happens after submittal? Any estimated timeframe for time after submittal for acceptance of NDA, panel review, PDUFA? Thanks.
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