The Amarin SPA appeals decision.
It is important to understand the importance of completing the entire FDA appeals process was not based on the chance FDA was going to change its mind and allow the SPA. After the first appeal it was a virtual certainty the answer was going to be no at all levels, because the initial decision came from the highest levels. The reason for completing was the federal courts insisted Amarin exhaust all remedies before coming to court, and indeed the SPA itself included full completion of the appeals process in this situation as part of the agreement. In order to go to federal court Amarin needed to finish the appeals process.
It is highly unlikely that the decision to drop the appeals process was done without consulting Covington and Burling, Amarin's lawyers. The question is why did they decide to abandon the option of suing the FDA in court. A plausible explanation initially was the FDA was going to throw them a bone. Perhaps a label expansion or something. Its now pretty clear after reading the NCE court transcripts and what has transpired in the last two days, that the FDA was never going to admit they were wrong, never going to negotiate..it was always 'all or nothing".
So what remains? IMO the decision was not made based on the costs of pursuing the appeals or the federal trial. B&C are up there with the biggest of the big as far as lawyers go. They were lead firm in the BP Gulf of Mexico oil spill, the top litigators in the country. They would not be gouging Amarin and not representing them if they did not believe they were getting screwed. The FDA appeals process is no more than sending the required forms to each level up the chain, this takes little more than a copying machine and some 8,1/2 by 11 paper...oh and waiting around a few months.
Only other thing that would make sense is they know something about the REDUCE-IT results. IMO that is a very distinct possibility. They have not told any of this, but perhaps the Baker Bros. and Stonepine were a little closer to the horses mouth. I have always believed that double blinding a study is very effective in preventing the clinicians caring for the patients and the patients from knowing who is getting the drug, but is much less a barrier to the people who monitor the events from figuring out what is happening. All they really need to know is the total events and from that point you can make some very accurate estimates of the drugs efficacy. Knowing the drug efficacy was at least thirty percent would make going to court unnecessary. Remember when JUPITER came out it was all over the front pages. Regardless of your and my opinion about the FDA, there would be little they could do about it.
":>) JL
