Raf
The FDA hasn't cooperated with Amarin since June 22nd 2012 Orange Book meeting. Instead they have withheld exclusivity, accepted "shame CP" to further delay exclusivity, falsely listed Anchor Ad Com agenda on Public Registry, Improperly notified Watson of exclusivity prior to granting 3 years NME, granted 3 years of NME in an arbitrary and capricious manner, rescinded Anchor SPA, delayed rescinded SPA appeals, failed to address 2014 Omnibus significant items by both branches of Congress, lost NME Moss ruling, notified Watson improperly again, delayed NCE, attempted to slither out of First case with Woodcock letter, lost injunction case, delayed First case by 7 months. Somewhere in here add retaliated against stakeholders by censoring CP & Pacira CEO (Amarin board Member).
The FDA has no intention but to delay NCE and First for as long as possible. Under no stretch of the imagination should they be trusted to deal with Amarin or stakeholders in a civilized legal manner.
Our ONLY recourse is to beat the FDA into a pulp using the laws of the land. Anyone that doesn't understand this hasn't been paying attention the past 4 years.
Amarin will file legally sealed R-I interim results, the FDA can do NOTHING to prevent this. Amarin will win PI due to real doctors viewing the data under Seal and oath. Whatever happens to the FDA after this isn't going to be Amarin's concern.
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