The FDA's dilemma..
None of us on the board, what the FDA is offering to "narrow the dispute."
It may seem obvious that the FDA is more likely to compromise on (disregard) marketing material regarding what benefits Vascepa may have, the importance of trig lowering, inflammation, etc. etc. Let the company say what it wants...Rather than simply allowing the sNDA label citing "New significant science.
I do not know what the FDA will offer, but I suggest the first action, compromise, is fraught with difficulties for both the FDA and the company. If the FDA relaxes the rules for Amarin, it is opening up the floodgates for every other company in Amarin's situation. From Amarin's standpoint, can they really believe the FDA will keep their end of the bargain. This sets up a situation where the FDA might later trap the company, claiming Amarin exceeded the agency's instructions and is guilty of deceptive advertising.
IMO the easiest path out of this "Mexican Standoff" is simply for FDA simply to grant the mixed dislipidemia sNDA. The FDA can easily and truthfully claim "New Science". Allowing the sNDA affords the FDA a way of getting around a difficult situation, where they are involved in some very controversial decisions, and already have egg on their faces from the blistering NCE decision. The problem for the FDA in the 1st Amendment case, is the possibility of dragging all their past behavior, including the AdCom, into the federal courts and we already have a preview of what the feds think of "FDA law".
Anyone who does not think the federal judge presiding over the 1st Amend case is not going to have read Judge Moss's summary, is dreaming. Prior behavior is not suppose to influence verdicts, but of course it does.
Anyway JMHO...I would be very careful in accepting any compromise that does not include the ANCHOR sNDA....My plea to the company..NO sNDA = 1st Amendment Trial.
":>) JL
