Does the following statement pertain solely to safety or can it be used as an excuse to hold off on expanding the use of Omega 3 treatment? Can they use outcomes as public safety concern? Or will they potentially use prostrate issues as a possible public safety concern? It would be horrendous if the AdCom seeks additional prostrate data as an excuse to hold off on the expanded indication. The wording according to this mornings announce is as follows......"An SPA agreement is generally considered binding upon the FDA unless public health concerns unrecognized at the time of protocol assessment are evident." Is this potentially what the AdCom will use as their out on the SPA agreement? I'm concerned that today's enrollment announcement is being viewed by the market makers as an indication that Amarin is hugely concerned about the AdCom outcome.
My major concern is the market reaction to the enrollment announcement. It seems not even what should be viewed as good news is helpful to share price. It is almost as if the market makers expect more of the same from Amarin.....historically in EVERY case the worst scenario possible seems to curse Amarin. I have never seen any company with such an incredible series of worst case scenarios developing. The slogan "If it were not for bad news there would be no news at all" seems to have been written for Amarin. I have never witnessed anything quite like it.
Volt....I know how you feel. And no doubt there have been events that have not helped. While I have been able to push my concerns aside, that has been up to now. The last 2 weeks have raised my level of concern. These past weeks have seen the PPS fail to run up into ADCOM, fail to recover from the TEVA lawsuit which hand nothing to do with Amrn, and now a failure of the PPS to make even a slight up-tick on the news today about Reduce It having over 6k patients enrolled. At some point you have to begin to wonder just what is going on. We (those of us on this board) cannot not be the only people who know what Amrn is truly worth. Wall Street is betting against this, the PPS is evidence of it. Just how many trading days left until ADCOM? And this cannot climb back into the 7's? Nobody else finds this troubling? If ADCOM was such a slam dunk, or even close to being a lock, there would be large amounts of money betting on it and the PPS would reflect same. This is just not happening......at least not now. It better change soon................
You said "I'm concerned that today's enrollment announcement is being viewed by the market makers as an indication that Amarin is hugely concerned about the AdCom outcome".
Yes, Amarin hugely concerned about the Adcom. They want to make sure that they could get all yes votes.
I was told they think every questions that Adcom might raise, and parepared all answers. They are very careful about off label scripts, they are making sure there are no any problem for the approval of Anchor. Great management!
If they don't care or concern about Adcom outcome, then you would say "they were careless".
The bar of approval expection has been reduced. That's Awesome! Once approval, AMRN would shoot up to the moon.
You appear to be in a protracted state of concern regarding AMRN...So much so that you put a negative spin on every event...My guess is you are not a concerned stock holder.
.Pray enlighten us on what new evidence has surfaced (publicly disclose, medical journals, etc.) which would convince the FDA to pull AMRN's ticket...Certainly not the fish oil "meta analysis", or the nonsense over prostate cancer which turns out to be due to DHA...which even you understand has been removed from Vascepa...More bricks are added daily to AMRN's wall the latest being the Japanese study..detailing both the clinical and pathophysiological evidendence supporting EPA's amazing posative effects on CVD and potential for other vast horizons...
The report from the company they are close to full enrollment in REDUCE-IT is a reflection of the competence of AMRN's management...The shorts have held sway since the convertible put a lot of phony short shares on the market, due to the obvious hedge...followed of course by the ill informed who piled on...
AMRN is doing just fine...you need not be concerned..