Amarin Corp Plc (AMRN)

[raistthemage]

Off Label Drug Marketing was Ruled Free Speech

And this was upheld on appeal

http://www.prweb.com/releases/2013/3/prweb10523505.htm

I am not enough of a legal expert to determine whether or not Amarin would have any realistic chance of suing the FDA for breaking their SPA because I don't know what the precedents are if any, but based on the free speech ruling Amarin could market itself openly as preventive cardiovascular drug. The main downside being it would have a lot more trouble getting expanded insurance coverage.

Based on this I think Amarin should inform the FDA (at the level of commissioner Hamburg if possible) that if they don't overrule their advisory panel their financial situation will give them no choice but to

1) Drop the reduce it study to conserve money, seeing that there is no point in continuing it for them if the company goes bankrupt or has to be sold at bargain basement prices.

2) Market Vascepa as a preventive cardiac and anti diabetes drug anyway.

If the FDA agrees with Amarin they overrule the adcomm panel we get the anchor indication.

If not we have a superior product which we market as a preventive cardiac drug anyway. No more dealing with corrupt FDA bullshit.

And no I don't think the FDA will pull it from the market, that risks all sorts of outside investigations.