Replies to post #275475 on Amarin Corp Plc (AMRN)

[HinduKush]

Well said Irishman
We need this clarity of sequential logic and thought.
++ FDA had to follow policy guidelines and bio equivalence standards were met- they were obliged to approve
++Better we digest this news now than later
++All hinges on winning the Appeal: we knew this yesterday as we do today

We need to steel our emotions develop some faith and not lose our way on the road from Gethsemane to Calvary

HK

[Greymatter1]

I-man: though I am not a lawyer I have extensive experience with the NY Court system and the Court of Appeals as it is related to my work. Plainly speaking if you get some Judges in the CAFC who believe they are protecting the sick patient by allowing for generics to enter the market and lower the cost, similar to Judge Du, their decision will be manipulated to reflect that view regardless of what the facts or even common sense are. I have seen it time and time again.
I have no new information other than statistically... winning patent appeals are very low.
And although I am more of a conspiracy theorist than reporter of fact, I have been of the opinion for many years on this board that there are nefarious forces at work against AMRN. Though it may not be some large coordinated plot (and it possibly could be a coordinated plot)...the overwhelming number of obstacles this company has faced and continues to face is not by accident. There have been multiple problems from the very beginning...
There have been truly bad companies (ie Tyco, Worldcom, Enron, Healthsouth...you get the point) that blatantly ripped people off and didn't face the constant headwinds that AMRN has. No real explanation but a head scratcher (basher?) for sure. We know many of these generic companies have boat loads of capital and are politically well connected so that may be a good place to start looking. Follow the money.
And I find it disturbing that in spite of the information we were given about product stability, manufacturing difficulties raw material availability, and supply chain, the generic version is approved only a few weeks after the DC decision???

[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

[sts66]

I think he meant that because AMRN is a cursed stock and company, it's obvious the CAFC will side with the generics.