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Re: Mellowmood77 post# 215188

Friday, 09/20/2019 3:13:40 PM

Friday, September 20, 2019 3:13:40 PM

Post# of 423968
The new guidance is directed at using CPs to delay generic/biosimilar approvals, not sNDAs - and IMO timing has nothing to do with MCR or AMRN - FDA issued an updated draft guidance around this time last year, and after taking public comments they finalized and released it the other day.

I believe MRC is working for someone, not with someone - he admitted on Twitter a couple days ago that he alone wrote the CPs, and shorted the stock to make money since nobody bought his "research".

Hadn't heard that someone here claims to have a source within the FDA that said "FDA felt bad about the late AC decision" - I'd take that with a grain of salt - this person would fall in a very narrow range of FDA employees, would actually have to be involved in AC decision, else it was 3rd party gossip around the water cooler between two FDA employees/contractors with specific interest in AMRN and the V sNDA.

The Thought Police: To censor and protect. Craig Bruce

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