HD...
" Court: the result more than questionable, definitely not a slum drunk. The first ruling won't be before 2017 and the final (after 1 or 2 appeal) won't be before 2019 ..."
Agree the FDA position is not going to change. The rest of your post is just conjecture. I was lead plaintiff in a Federal Court case and have a very good friend who is a federal judge. The company if it pursues the appeals could file in federal court before the end next year. Filing in federal court costs less than $100 K and regardless of what some of the self described court experts on the board say, there will be law firms lined up to take the case on contingency. It's a high profile case.
In my experience the federal judge did everything in his power to settle issues without a trial. The issue here is going to be the SPA rescission and IMO there is an overwhelming likelihood the judge is going to look at the evidence and say the FDA acted improperly and irresponsibly by not informing Amarin in a timely manner of its change of mind, new scientific issue, or whatever the FDA's reason for the rescission. IMO the AdComm itself is going to throw the FDA into a very bad light, particularly its use of a trick question.
Let me explain exactly how it worked.
The question was.. "Do you believe (true or false) Vascepa’s beneficial effects on the studied lipid/lipoprotein parameters (ANCHOR) are sufficient enough to grant approval for co-administration with statin therapy for treatment of patients with mixed dyslipidemia and CHD or CHD risk equivalent prior to the completion of REDUCE-IT?"
At first glance the question appears to be a solicitation of an opinion, but in reality it was modified a "True or False" question in which there was a right and a wrong answer based on the fact the "studied parameters dealt only with trig changes and not on therapeutic benefit so they offered no guidance regarding whether or not Vascepa would lower CVD in statin patients. The correct answer is no (false)..Two out of the eleven voters got the question wrong.
By continuing with the FDA appeals process Amarin is not spending a pile of cash. They are not forced to take the case to court, merely keeping an important option open. IMO they must have some good reason for not continuing.
JMO ..":>) JL
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