Amarin Corp Plc (AMRN)

[Biobillionair]

STS it's exactly implied by the FDA's own words:
WARNING!!! Do not ignore the truth, it's provided to you in the FDA's own words. The FDA didn't grant NCE due to large indication and 8 generic ANDA itching to file. This decison was ponitifacate for 18 Months directly damaging Amarin's ability to conduct business. Anchor was rescinded for the very same reason.



The following are direct quotes from the 2014 exclusivity meeting prior to Janet Woodcock granting NME on 2-21-2014:

"Amarin Pharmaceuticals Ireland Limited and its U.S. affiliate, Amarin Pharma Inc. (collectively, Amarin) have requested that the Food and Drug Administration (FDA or the Agency) recognize 5-year NCE exclusivity for Amarin’s drug product Vascepa (icosapent ethyl) Capsules (new drug application (NDA) 202057).1 Amarin claims that eicosapentaenoic acid (EPA), the single active moiety in Vascepa, was not previously approved as an active moiety of any
WARNING!!! Do not ignore the truth, it's provided to you in the FDA's own words. The FDA didn't grant NCE due to large indication and 8 generic ANDA itching to file. This decison was ponitifacate for 18 Months directly damaging Amarin's ability to conduct business. Anchor was rescinded for the very same reason.

REDUCE-IT changes nothing under these circumstances, the FDA wants to give REDUCEIT to the 8 Generic filers and you must act now to stop them. WE MUST GET THIS INFO TO CONGRESS, PRIOR TO THIS TUESDAY HOUSE MEETING.


The following are direct quotes from the 2014 exclusivity meeting prior to Janet Woodcock granting NME on 2-21-2014:

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Currently, eight abbreviated new drug applications (ANDAs) have been submitted and are awaiting a filing decision. If FDA concludes that Vascepa has 3-year exclusivity, the Agency can receive any pending ANDAs that are otherwise sufficiently complete to permit a substantive review. If FDA concludes that Vascepa has 5-year NCE exclusivity, the Agency must refuse to receive the ANDAs until at least 4 years from the date of the initial Vascepa approval. The Exclusivity Board concludes that Vascepa is not eligible for 5- year NCE exclusivity, because EPA, the single active moiety in Vascepa, was also an active moiety contained in another, previously approved drug, Lovaza (omega-3-acid ethyl esters) Capsules (Lovaza). Accordingly, the pending ANDAs are eligible to be received (if they otherwise meet the criteria for receipt of an ANDA)."