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Re: Samsa post# 17885

Thursday, 09/22/2016 10:28:20 AM

Thursday, September 22, 2016 10:28:20 AM

Post# of 38634

they need to "prove" that statement and that can be done through the NDA-S pathway. a much shorter timeline than starting over with a new NDA.


and what is your timeframe for this NDA-S - what is your time estimate as to when IPCI will submit the NDA for the PODRAS FDA approval???