Amarin Corp Plc (AMRN)

[HDGabor]

L-

Are you sending a letter to BOD (inc. JZ & JT) to remove JT? …

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“None of this happens until there is a change in management at the company. NONE. I really don't understand how you still do not see this yet.”

I do not see it, since I do not see anything that confirms it. We have a different view on different topic:

I could agree, if they stop R-IT they are incompetent, however I do not think it, since the company / Vascepa was and is about R-IT always. Not Marine, not ANCHOR – these are just tools.

PPS is a sentiment of the market about the potential of the company, so conclude anything regarding the management based on the level of it is false.

PPS was high due to Marine approval and BO expectation. Based on Marine only nobody value the company for $10+ on a short-term. Was any BO offer? Definitely. Was it high enough? I do not know. As of today we could say, yes it was high, however – maybe – two years later we will say good move to turn down that silly $20 offer. We do not know yet, that it was bad or good decision, it just looks like as bad now. I am sure that the company made a valuation and refuse the offer due to low offer. A lot of people will booo, but management “lost” more than any of us: insiders still own 6,7M shares …

Really, what was the mistake done by the management during the ANCHOR sNDA? Refused the FDA’s offer in January? I never see any realistic / logical version from anybody (including you) about it. SPA modification? Joke – study was done, data analyzed and SPA is not about indication. BBW? Are you really think that if it is the diff. between them, AMRN refused it? They want R-IT label? Assuming that any company running a trial would like to include it in the indication is not realistic.
I do not think that they will appeal or if yes, it worth anything, but if they will I am sure that they will have a good reason to do it.
Suing FDA? They will not, since could not before go through the whole appeal process up to MH.

CRL: I am give a minor chance for other outcome, but based on FDA past action it has the highest possibility, so I will not be surprised.

NCE: How is it management related? AMRN developed the new drug V, it has a new active ingredient (FDA agreed), FDA based on their regulation (active moiety approach) did not grant NCE, however the statue contains active ingredient and based on previous case I think that the court will reverse the decision. But let me know, how any other management could get NCE status for the V?

„It is not the FDA's fault this stock is trading at $1.44.” – really? Meanwhile, FDA “noted that there were ongoing cardiovascular outcomes trials -- ACCORD-Lipid, and AIM-HIGH, to name two -- that these trials would provide important information on the incremental benefit of adding second lipid-altering drug to statin therapy.” during the pre-IND meeting in 2008 and the studies were published in 2010 & 2011 they could not conclude anything till the BD. The study result were irrelevant regarding of V. Why not cited a study about adverse effect of fishing? That has more relevancy …

Are they hating AMRN’s management, were they irritated by any of them or by the management bonus plan? I do not think. But if we accept it for a second, how could be the approval of a safe, effective drug influenced by person, against the most science?

So, is it FDA’s fault or not? It looks like yes.

What will be a next step? I do not know. Of course as all of us I am speculating. Maybe:
- they will appeal further (I do not think)
- they got an answer as based on the info at the time of the rescission it is uphold, bur submit the new info (post analysis of V, NEJM articles) to DMEP and we will see
- they will try to modify the R-IT’s SPA to make an earlier interim analysis

We will know soon. I understand your feeling and thinking, just do not agree. We have to "step back from the fray for a bit to regain a proper perspective." (c) - not mine, but agree.