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Re: InTheTrenches post# 16890

Thursday, 08/04/2016 5:21:34 PM

Thursday, August 04, 2016 5:21:34 PM

Post# of 38634
Trench....I personally dont follow Eaglet. it never interested me. I chose IPCI over them. that being said, what was the time line from filing to panel recommendation? also, from your other post concerning the NDA and them having to provide that manufacturing information. just curious then, if they do have to provide it, how they will? 1. we know they can not import into the US so they need a manufacturing partner who is US based. 2 they have not released any deal? so my thought is, they either will announce a partnership prior to filing OR if the information is not required, they wont partner yet. I have not been able to find that requirement in the 505(b)(2) pathway as of yet. I have been looking.