Amarin Corp Plc (AMRN)

[jessellivermore]

HD..

Thnx for the comments.

We are talking 6-8 months here, and one important scenario you are not entertaining is the possibility the R-IT results come in positive and the FDA still does not allow the labeling change.

How you ask could they do that..Well look back at the AdComm. The FDA could manufacture more excuses...bleeding problems, the placebo. How can you trust them?

I would write a 0ne paragraph appeal in both cases to limit the FDA's stalling. We already know what the FDA's final reply will be..In the meantime the company should be planning the breach of contract suit. Sad to say, I believe our best hope lies in the Federal Court.

As far as the FDA's rescission IMHO this action was not legal. The definition of "significant" in terms of either safety or efficacy, required to violate the contract would be such (borrowing from the PTO) that one skilled in the art would agree with the FDA's conclusion. This is not the situation here. There are two parties here and Amarin does not agree with the FDA. The lipid societies..read experts..do not agree with the FDA.

The SPA is very specific. This must be new scientific evidence. There is no new scientific evidence regarding Vascepa or its API. Mulling over studies base on entirely different APIs requires a "leap of faith" on the part of the FDA. The kind of leap of faith that flies in the face of the entire FDA process.

":>) JL