This is a contract with a built-in exit clause. Read the PR. It spells out clearly that the FDA thinks the exit clause is satisfied. You should assume they ran it through their legal department. The FDA will be proven wrong by Reduce-it, but by that time, it will be too late for Amarin. Never saw anything this unfair since DNDN. Anyway - unfair, idiotic, irresponsible, putting the patients in harm's way, etc, all those do not equate illegal.
" [ . . . ] the FDA has rescinded the ANCHOR study special protocol assessment agreement because the FDA has determined that a substantial scientific issue essential to determining the effectiveness of Vascepa in the studied population was identified after testing began. Specifically, consistent with discussion at the Advisory Committee meeting, the FDA cited results from the ACCORD-Lipid and AIM-HIGH outcome trials, as well as the publicly presented results from the HPS2-THRIVE outcome trial, which the FDA stated in its October 29, 2013 notice to Amarin, fail to support the hypothesis that a triglyceride-lowering drug significantly reduces the risk for cardiovascular events among statin-treated patients with mixed dyslipidemia and residually high serum triglyceride levels (200-499 mg/dL). Thus, the FDA stated that it no longer considers a change in serum triglyceride levels as sufficient to establish the effectiveness of a drug intended to reduce cardiovascular risk in subjects with serum triglyceride levels below 500 mg/dL."
Sadly, no approval around any corner near us. The FDA has made up their minds and the arguments are irrelevant as far as the FDA is concerned, as is the public health.
Thank you for your time and effort.
I am afraid he has not convinced me. Obviously, he said all the right things, but given the FDA's clear stance, the company cannot avoid what's coming.
This is a mess.
Again, despite my skepticism, I do appreciate what you are doing.
Unfortunately, the FDA is going to deny the application pending Reduce-it results. I don't know under which paragraph, but their arrow has been shot and the FDA will have no problem drawing the circle around the spot where it hit the surface. This circle will then become the new model.
Your prediction may or may not prove true. Anyway, in case it is correct, you could still wait for the first dilution before buying.
They WILL pursue Reduce It. They know Marine cannot sustain the company. They may or may not be still alive by the time Reduce It is done, but they have to aim for it. Counting on Marine alone would be committing suicide.
Unfortunately, the FDA will not go against the AdCom in this case. Anchor will be approved after Reduce IT if the company is still alive.
We have really good reasons to expect to be very, (VERY!!!) happy with the results when they become available, so that's definitely not the question.
The question is, would you be happy to wait several years for approval?
An all-time high is an all-time high is an all-time high. A very good thing as far as that topic is concerned.
On the other hand, we need the positive recommendation, followed by approval, otherwise the Marine numbers don't mean shוt.
Yes, I know this is not as important right now as the big binary event (and I know we cannot thrive on Marine alone), but here we go: New:3177 (up 2.68%), Refills: 3078 (up 8.53%). Both numbers are all-time highs.