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  • Amarin Will Receive A Positive Vote By The Advisory Committee [View article]
    Anyone that is predicting doom and gloom should note the recent purchase by AZN of Omthera - given Amarin already has approval, that might be considered a worst-case scenario buy-out wise, in light of the fact they already have REDUCE-IT enrolled, etc.
    Oct 18 06:40 PM | Likes Like |Link to Comment
  • Lesson About The Risk-Reward Profile For Amarin Investors [View article]
    There are three paths forward for Amarin - and canceling REDUCE-IT is not one of them.
    Oct 18 06:30 PM | 3 Likes Like |Link to Comment
  • Lesson About The Risk-Reward Profile For Amarin Investors [View article]
    I doubt an article made anyone lose money. I've written plenty of bullish articles based on the science and the potential market, as have others, but everyone has always known that the FDA AdCom and PDUFA dates were binary events that could go either way. I personally thought the FDA was a bit harsh and subjective on Wednesday, and am someone who lost money, but at the same time I do not feel the urge to be rude and mean to people who were successful as bears. It would be better if you were a bit more professional in addressing your reader comments, instead of coming off so smug and rude.

    If I were you, I would also be careful about the things that I write, including referencing that a drug can cause brain tumors - I would love to see a cite for the fact that EPA does so, as I have pretty much read all of the literature and have yet to see that.
    Oct 18 06:29 PM | 4 Likes Like |Link to Comment
  • Lesson About The Risk-Reward Profile For Amarin Investors [View article]
    Yazzbro, you are correct, and although I am by no means the bull I was before AdCom, I do know that the company is intending to meet with the FDA and discuss the differences in what was proposed at AdCom as the question, what was the actual questions in the briefing docs, and what the actual indication being applied for. Although I think the bearish case is much more prevalent now, there is definitely some room for a surprise in December. I also think there other factors that could also lead to a surprise between now and then, so it should be most interesting.
    Oct 18 06:26 PM | 2 Likes Like |Link to Comment
  • Lesson About The Risk-Reward Profile For Amarin Investors [View article]
    Serenas, I'll help you out here - the drug does help people exactly how advertised, and for the indication being sought - that of lowering triglycerides. There have been some concerns about the drug's effect being impacted by some strange things seen in the placebo group, but in turn this could be countered with its main competitor also seeing concerns in a placebo group previously.

    So, the drug does help people - both in the MARINE indication and the ANCHOR indication (the differences being in the trig levels per mg/dL). Where Amarin ran into an issue is that the FDA basically attempted to push forward beyond the applied for indication, reasoning (in my opinion not correctly) that the only reason to lower trigs is to lower CV risk - despite the fact that there are other reasons, such as avoiding getting trigs into the range where acute pancreatitis is a problem.

    The SPA does mean something - it is both an assessment and an agreement - but to what extent it will mean something going forward will in large part depend on how Amarin negotiates with the FDA regarding a label, indication, and how effective they present their case in terms of risk/reward going forward - especially in light of the economic realities of the REDUCE-IT study.
    Oct 18 06:24 PM | 3 Likes Like |Link to Comment
  • Amarin Will Receive A Positive Vote By The Advisory Committee [View article]
    The first two paragraphs you wrote made sense, but the last one I've a bit of trouble with.

    The LDL effect of Vascepa is minor, but the whole point was that it didn't raise LDL to the same level of statistical significance as did Lovaza/Omacor in the COMBOS trial.

    I fail to understand where you get the "drug is less effective at reducing TG than Lovaza" - care to explain?
    Oct 18 01:29 PM | 1 Like Like |Link to Comment
  • Amarin Will Receive A Positive Vote By The Advisory Committee [View article]
    I think you are wrong Dave, and as an investor who got it wrong, I'll still call you out on something specific that you said regarding the study results. The problem had nothing to do with prior studies, plain and simple. It instead was the result of the FDA, for whatever reasons, twisting the language to turn the Advisory Committee vote into a vote on the REDUCE-IT indication, instead of the proposed one. Plenty of people at fault there, including the company management, but let's not twist facts that don't exist. The AdCom is supposed to rip apart studies and such, and if the vote had actually been about the intended indication without being subjectively changed and interpreted to be about lower CV risks, then the day would have turned out differently. That said, it went how it went, and bulls were wrong, regardless of the end reason.
    Oct 17 04:56 PM | Likes Like |Link to Comment
  • Amarin Will Receive A Positive Vote By The Advisory Committee [View article]
    I've been a big fan of the science for awhile, but that lack of action combined with the tone of the conference call last night really made me question a few things about the abilities of the management team.
    Oct 17 02:23 PM | Likes Like |Link to Comment
  • Amarin Will Receive A Positive Vote By The Advisory Committee [View article]
    I think today the panel actually wanted to vote in favor of Amarin for the indication, but the FDA literally kept pushing the outcomes to the point where they actually answered a different question than was asked on paper. I 100% agree with the sentiment you expressed, and felt like I heard similar things from the committee members.

    In terms of the buyout value - I've been pondering that for hours now. The patents, the studies, the approval, etc - they all have value, and I could ballpark what I believe. However, the issue moving forward is the cash pinch + lack of plan. The company sounded desperate and defeated tonight, and that is not necessarily the best bargaining the position to approach big pharma with.

    I suspect that if an offer comes along, it will be a PPS max value of $7 with milestone payments/contingent value rights that are based on sales and REDUCE-IT. If I was Amarin, that's the route I would go.

    However, there is the possibility still that a Pfizer could just acquire and then do a tender - if so, the control premium might increase that PPS.

    Your last point - nothing today indicated that Vascepa was not in the best in class - but rather that the FDA didn't want to make another mistake regarding approving a drug for CV outcomes that proved to be worthless.
    Oct 16 09:55 PM | Likes Like |Link to Comment
  • Amarin Will Receive A Positive Vote By The Advisory Committee [View article]
    So, this is my general closing comment on this, and the fact is that the Bulls and Longs got it wrong. I don't really think we got it long in terms of the science or the question, and I expect ultimately the science will come through.

    Where I got caught with my proverbial pants down here was in the wording of the question - the discussion made me pause, but the actual question said one thing, and so I thought that was what the panel would vote on. To say that I was shocked today that the vote was on CV reduction would be an understatement.

    I am not one of those people that points a finger at management for my mistakes, and I own getting this one wrong. I will say, however, that I was sorely disappointed in the management's seeming lack of preparation for certain questions today, and perhaps more important, the absolute failure to give any type of pushback as the question was being asked. The FDA clearly had an agenda in fighting against the change of wording, but Amarin itself should have had someone step forward and stress the indication they were seeking. I was shocked that they had no type of response, even something as simple as "We seek to treat people here to keep them from progressing into the very high range and avoid the risk of acute pancreatitis. Disappointing performance.

    To all of the longs, keep your heads high. You can never win if you don't play, and at least you had the gumption to step up to the plate and take a swing, something most people never do.

    To the shorts, congratulations on being correct about the ultimate result.
    Oct 16 04:30 PM | Likes Like |Link to Comment
  • Amarin Will Receive A Positive Vote By The Advisory Committee [View article]
    Sorry to hear that Frank. Best wishes to you moving forward.
    Oct 16 04:25 PM | Likes Like |Link to Comment
  • Will Cardiovascular Concerns Jeopardize Amarin's Upcoming FDA Advisory Panel? [View article]
    I want to echo John's statement, as his point about looking at both documents as equally important is something that has been constantly overlooked. The FDA reviewer is supposed to bring to light any potential issues, reasons to say no, etc. It's the equivalent of the devil's advocate document. That is the whole point of the reviewer with the AdCom - to raise any and all potential issues.
    Oct 15 06:32 AM | 7 Likes Like |Link to Comment
  • Will Cardiovascular Concerns Jeopardize Amarin's Upcoming FDA Advisory Panel? [View article]
    Well-written comment.
    Oct 15 06:30 AM | 7 Likes Like |Link to Comment
  • Amarin Will Receive A Positive Vote By The Advisory Committee [View article]
    SJunk, I had previously read that, and a few others in random subgroup populations including diabetes, etc. The FDA reviewer got the time to paint the skies grey, which is exactly what is supposed to happen, and I fully expect our experts to bring out the blue skies.
    Oct 14 11:16 PM | Likes Like |Link to Comment
  • Amarin Will Receive A Positive Vote By The Advisory Committee [View article]
    Thank you for reading and commenting. Much appreciated.
    Oct 14 11:14 PM | Likes Like |Link to Comment
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