Hay-Amarin's not going to PR anything except R-I material information. AMARIN was taken to court 2 times after ANCHOR SPA rescindment based on 'over statement' of FDA reliance on SPA's.
Nor has Amarin PR'd recent patents regarding treatment of NASH (fatty liver disease) or the combo NCE with hydroxyl-Lipitor.
Amarin doesn't PR strategic plans due to ANCHOR rescindment backlash IMO...and this is directly the FDA's fault for NOT following SPA guidance, Ad Com guidance,scheduling of type A meeting guidance, NCE guidance, generic drug communications guidance, and numerous MAPPs related to good review practices. Now the DOJ will not support lawsuits regarding any FDA guidance documents without certified OMB numbers....current I believe this number is at zero guidance documents.
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