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HDGabor

10/05/17 8:38 PM

#115610 RE: concapk #115607

c-

Both of you look at it from a medical viewpoint which you are 100% correct ... I look at it from a business viewpoint as does BIO

Nothing is further than consider my viewpoint as medical. As always I write about medical issue as less as possible, as required by the relevant topic for my business viewpoint.

To avoid any doubt (again): I did not like the FDA action / habit, don't give the FDA any positive credence for what they did ... however the fury, disappointment do not overshadow my perspicacity.

For clarity: I did not see a piece of post (info) that was well-structured, was based on valid argument (and wasn't on "feeling" only) about how FDA violated any law / regulation.

I do not have any problem with any opposite view ... if it is factual, supported and isn't "because said" only ...

Best,
G

Biobillionair

10/05/17 10:29 PM

#115612 RE: concapk #115607

An accurate assessment IMO.
BB

ziploc_1

10/06/17 6:36 AM

#115622 RE: concapk #115607

C......."AMARIN was, an is a small company required to run a 7000 modified to an 8000 CVOT study costing approx. $250/300 million.
This study called REDUCE-IT would take approx. 4 years to complete and that cost would be mitigated by sales from ANCHOR approval. The FDA knew that they would be harming AMARIN by rescinding the SPA, "THEY DIDN'T CARE".

IMO the FDA was guilty of extortion......They used the Anchor SPA as bait to extort from Amarin a R-IT study BEFORE(i.e. in return for) their considering Anchor). Then ,once the R-T study was established, the FDA pulled the rug out from Amarin at the Adcom, rescinded the Anchor SPA, and left Amarin for dead, hopefully to bury the evidence of their misdeeds.