Amarin Corp Plc (AMRN)

[NickHous]

Montana, are you saying that the FDA position could be that the aNDA filings by the generics impose upon the exclusivity of AMRNs patents? Could the FDA take that position regardless of what Judge Du's decision meant? I mean the case is on appeal and the position of the FDA is the position of the FDA. Would the FDA hold it's line of thinking that aNDA granting to generics would actually impose on Vascepa's patents already granted? Or could the FDA opine that a generic would oppose on Vascepa's Red-It label if granted? I mean who has final say here? FDA or Judge Du's ruling? I would think FDA has more knowledge in the matter of inducement of a label than a Judge. FDA and US PTO would have more knowledge and weight than a judge on whether inducement would occur. Am I not thinking right? Does the medicinal and scientific "ruler of the US" (the FDA) not carry the final say-so in this matter? Could that be our saving grace? In that the FDA will not follow an illogical inducement of a label for Red-It just because a prior label granted was found obvious by a judge. Could the FDA basically opine that Red-It is not obvious and by granting this generic label for Marine it would induce upon other label indications? Could the FDA withdraw the Marine label on their end and rule to mirror what the label will be in EU? In that this is now a CVD risk reduction drug and not a TG lowering drug at all? Not sure if anyone has wondered what actions FDA could take in this aNDA by generics. It's sitting out there and the FDA is the one that has to take action on this. Could the FDA "retreat" and spend lot's and lot's of time debating internally what this means to their label indication's they've granted. I mean the FDA definitely does their own thing and this could be precedent setting ruling by the FDA granting an aNDA to a generic that is trying to "back door" and steal another indication plain and simple. Sorry so long and sorry so many "?"'s, I just started throwing it out there. Nick