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jessellivermore

10/23/15 9:28 AM

#62216 RE: BioChica #62212

Fast times at Amarin High..

Now contemplate a time when fall nips the air and excitement fills the gathering board. It is one week before the Amarin/FDA settlement letter and two weeks before the CHERRY picking.

It would seem the 1A situation has gone badly for FDA and even more importantly FDA seems to understand how badly. The unlettering of their nasty letters, which sound less like communications between a government agency instructing a law abiding biotech, and more like mob threats, can only mean FDA is running scared..The recent suggestion in a published opinion suggests FDA's decision in rescinding the SPA could be worse than simple breach of contract. It could be unconstitutional. If that proves the case, and I see absolutely no reason why Amarin and its legal Seal Team would not pursue that possibility. This would rip the case out of the FDA's kangaroo court and into federal court where FDA has shown about as much ability as Tampa Bay did its first year in the NFL.

IMO the two most likely scenarios. One is FDA grants a label expansion or takes action to reinstate the SPA. The second is they request another delay period. It is Amarin that holds the sword in this fight. The sword meaning they have the option of continuing the 1A trial. IMO this would be very damaging to FDA not only because it would lead to legal sanctions on the agency, but because it would necessitate congressional action that could curtail FDA's authority. Additionally, it is likely to prove very embarrassing to FDA because these erased letters and many more are going to surface, and expose FDA for the thugs they are.

In two weeks ..The long awaited CHERRY study...Since this is in the afternoon of the first day, it is more likely I will attend...also get a chance to check the temperature regards Amarin..

So cheer up..and don't listen to the bad man..The PPS has the dwindles right now, but the volume is anemic. Remember biotechs go up only when there is good news, and they go down when there is bad news....or no news.

":>) JL