Replies to post #34951 on 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

[rafunrafun]

It seems to me the there is a missing ingredient... we need someone with prior history in dealing with FDA, someone who the FDA trusts and will get paid hefty if successful.

Also, you say it's moot to sue the FDA because if the lawsuit and REDUCE-IT are both successful, they'll both conclude almost simultaneously. I have several issues with this:
1. You say we may gain 6-9 months. I ask you, could your calculations be a bit off, for each, say by 6 months (court expedites this or FDA gives up or AGREE TO SETTLE TO AVOID DISCOVERY or any one of many other uncertainties), then our gain would be 18-21 months and that's certainly a significant difference.
2. If we win the suit and terminate REDUCE-IT early due to efficacy, aren't we suing for $$$, which we won't receive if we don't sue?
3. It seems to me that we need to put something on paper with the court, in case the REDUCE-IT is successful but the FDA still don't approve. Sounds unalienable but we all know what happened with SPA.