Amarin Corp Plc (AMRN)

[jessellivermore]

Irish...
To the point..nice post...FDA generic approval is SOP..Generics only need prove the API levels over a period of hours are the same as the Brand...That is what bio equivalent means in the FDA....

FDA is not selling us down the drain or favoring Hickma..They are doing their job..If the decision in the AC is for Amarin then Hickma will merely have shown bio equivalence...

I like our chances in the appeal as Vascepa effects can hardly be obvious if the FDA label states the benefits of Vascepa in very high trigs in treating Pancreatitis and/or CVD events have not been determined..And this is 20 years after Mori. The FDA clearly does not think Vascepa's actions are obvious..

';>) JL