I doubt I will post more than what I am about to here. First off I would like to congratulate longs on this board and continued success, especially those who believed in the science long ago when the FDA did its damage in 2012. Having been in several biotech stocks where the same thing happened, only to be approved much later (DNDN and NKTR), is gratifying.
Before I mention AMRN, as a way of credentials. I am an MD who regularly treats patients with a wide variety of heart disease. I also have heart disease and a strong family history of such, having had a quad bypass. I work with residents, teach, and publish in medical journals, am facile with my own statistics and have taught statistics and Evidence Based Medicine (NNT, NNH etc, which I have seen mentioned in posts here). I have had some success investing in biotech, having been in several stocks with byouts (JUNO, KITE, RLYP (made 6 figures in 1st two); and was right the FDA would approve two other stocks (DNDN, NKTR (Exubera), only to lose money after the tortorous waits when uptake of their products was abysmal. I followed the ADCOM meeting in each case and am familiar with the process.
I myself was also briefly on a fishoil supplement after my bypass, until my cardiologist decided it wasn't worth it after earlier studies showed no benefit.
To put it midly, I was flabergasted with the results of RI last sept. Not just a surrogate market study, but an outcomes study, performed over years, with thousands of patients; not in an area of total unmet need, but where there is a great continued unmet need. Since sept I have invested quite a bit in AMRN. While I understand, from a pure scientific standpoint, the possibility of a mineral oil issue, I personally do not beleive it is real. I have seen hit pieces from the same biotech writers, who you are all familiar with, in the past, and while this type of nonsense can cause further delays in the FDA approval, I do not think it will happen with AMRN and Vascepa. That AF has taken a 180degrees change from his original criticisim to me is significant.
I think JT is doing a phenomenal job in pre FDA marketing and have seen multiple ads across multiple major stations for Vascepa.
I started taking Vascepa myself 3 months ago and was initally somewhat disheartened, as the cost with insurance was over $350/month. I went through the review process, which entailed someone asking me (as my own physician) if my TG was over 150 and whether I was on maximum statin therapy...and though I was approved, the price was still more than I expected. I believer, with approval, that this will significantly drop.
I really appreciated people like SAM81 posting script data on a weekly basis and love those who publish projection graphs on twtr using this data. Great visuals. Scripts are bound to bounce around a bit, and I am not concerned about the drop this week. One factor to consider is that there are probably a core number of physicians who currenty write for Vascepa, and after a period of time, they will start to max out on those of their patients who can be placed on it. I think this could account for small minor decreases in script numbers, but that In the meantime, and esp with FDA approval, the number writing scripts will continue to increase dramatically.
Which comes to part of the reason I am writing this now. Without giving specifics, I very recently saw a patient who I noted was on Vascepa. I asked who placed him on it, expecting him to say it was his primary doctor. He told me he had been on some "krill oil" for his heart disease, and his cardiologist recently said to him "I have something a lot better". I know we've all been excited about ADA and endocrinologist backing the data/science, and that most have been hoping for that cardiology approval.
Perhaps the ACA will be conservative and wait for FDA approval, hard to say, but no matter, it will come. BUT... for a cardiologist not to just say there is something else I can put you on, but I have something "a lot better", gets me excited.
Regarding an ADCOM, I doubt the FDA will request one at this point but agree we should know within 2 weeks. If there is no ADCOM, they will absolutely give full approval. Even with an ADCOM, the chances of full approval are extremely high. The longs here saw the FDA ask for more data in 2012, and I guess the FDA could always scew AMRN again (I've seen other stocks where people say the FDA approved a study, only later to have the FDA say they had sent concerns about study protocol). So, for that reason I have some cheap 17.50 July puts. Probably wasted money... but I've been burned before, and my profits from the last 3 days have more than paid for them. I doubt I will need to buy any more after mid July.
The only other issue I wish there was more information and research on, is the patent one. From what I understand, the trial is not until Jan, and a similar patent problem was settled. Hopefully this one goes away, soon. Having been involved in an internet security stock patent company (VHC vs AAPL), I know all too well how long patent cases can drag on. However, AMRN can continue to sell Vascepa, even if it drags on for years.
Regarding a BO, i initially did not want any of my previous BO candidates, to be bought out. Greed I guess. In retrospect, it was better JUNO and KITE were bought out, as they were expensive drugs and profit without further risk was probably the best thing. With AMRN, I really hope there it no BO, as the potential is truly massive. An annoucement for a European partner would be great, but GIA baby.
