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Re: wimuskyfisherman post# 32511

Monday, 02/05/2018 12:01:51 PM

Monday, February 05, 2018 12:01:51 PM

Post# of 38634

Part of the problem with IPCI is their FDA applications are not good enough...



Well - that's my fear too. They do not want to do it well or simply don't know how it should be done.

That's why I don't trust NDAs at all. If they have difficulties to have ANDAs approved, they will never have an approval for any NDA.

"Clear path to approval" are a bit too big words for them.

They simply need someone, who has enough experience in this kind of applications.