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Invest83838

05/24/17 9:59 AM

#106812 RE: talleyville0311 #106811

I Think It Legally Proves That


Amarin Management was really blindsided by FDA

and they should have sued FDA at least a couple of years ago.

But since they haven't done that yet,

It is probably too late.

Amarin doesn't want to now PO the FDA before Reduce It results are known and, assuming that the results are good, they need FDA's good graces and approval.


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Biobillionair

05/24/17 10:35 AM

#106816 RE: talleyville0311 #106811

No, instead we have great evidence to submit regard the FDA's intensions and said intentions. For example, Dr. Jenkins justified the reason to rescind and additionally deny the appeal, "was based on the accumulation and totality of scientific data and information, including reevaluation and improved understanding of the relevant scientific knowledge, that have become available since the ANCHOR trial began...". If you remember, the EPADI Citizen Petition brought to the attention scientific information the FDA ignored to based their "scientific" decision on, instead the FDA cherry picked studies that weren't scientifically powered to study TG. Then the FDA proceeded to censor this petition and finally deny the petition on the same day they issued Amarin the ANCHOR CRL.

Amarin longs should own this docket: https://www.regulations.gov/document?D=FDA-2015-N-2002-1990

The Amarin story needs to be told from the eye of the biotech investor, the FDA violated the EPADI First Amendment rights when they outright censored then ignored our opinion.

BB