Amarin Corp Plc (AMRN)

[jessellivermore]

HDG..

We talked about this earlier and agreed, but since I have changed my mind.

FDA has agreed to negotiate a settlement to avoid a potential precedent setting 1st A decision (when piggy-backed on Caronia) which would create major damage and curtail FDA's most important property which is its authority. Letting the PI ride is a minor decision which will have little effect on the FDA. The 1st A suit is another matter. Amarin (Amarin's lawyers) know that and they are going to demand something valuable for dropping the suit. This is very similar in nature to a mal practice suit being settled out of court.

What else does the FDA have to offer. Certainly not the NCE which has been granted by Judge Moss. The truthful speech is also theirs. Englharte has forbidden FDA to prosecute Amarin for mis branding if their promotion is restricted to truthful off label language. The only thing the FDA has to offer is a label change. If you have another suggestion, I'm all ears.

The FDA has changed its mind about drugs many times in its history. Some it removed, others it reconsidered and granted NDAs, aNDAs and sNDAs. Time has past since the AdCom and "New Science" has most certainly come to the agency's attention....

":>) JL