Seeking Alpha

Amarin falls as investors digest advisory committee briefing documents

  • Briefing documents are now available for Amarin's (AMRN -8.9%) upcoming FDA Advisory Committee meeting regarding a high triglycerides and mixed dyslipidemia indication for Vascepa.
  • The stock is trading sharply lower as investors sift through the 115 page package.
  • It seems some traders are keying on the following statement from page 57: "The changes in lipid and lipoprotein parameters from baseline to week 12 in the mineral oil placebo group are rather atypical for a trial that included a stabilization period for diet and lipid-lowering therapy, raising the possibility that mineral oil may not be as inert as assumed. If true, the treatment effects observed with AMR101 may be overestimated."
  • Full set of documents here.
Comments (17)
  • Quoth the Raven
    , contributor
    Comments (2124) | Send Message
     
    Painting lows again right now - 13% down - how low can this go today before speculative buyers come in?
    11 Oct 2013, 02:58 PM Reply Like
  • tonyrwynn
    , contributor
    Comments (7) | Send Message
     
    Just finished reading the FDA briefing docs - key to me is that in both the MARINE submission and also the Lovaza submission there was also an increase in lipid and lipoprotein parameters in the placebo groups between baseline and study end. Think the price drop may be an over-reaction...but of course this depends which way the advisory committee go!
    11 Oct 2013, 03:17 PM Reply Like
  • Frankyie
    , contributor
    Comment (1) | Send Message
     
    My feeling is, that the FDA has it in for Amrn and they have in no way made it easy for any of the trails and when it come to approval on both products, well we all know the direction the Panel has gone, nothing but negative in every findings.. The FDA and lack of support for so many years, will cause this company AMRN to fold. The market Cap of Amarin has been shattered and if the stock falls any further, to 3 or 4 Dollar a share... it might be over for this company and all jobs that are lost, will be the doing of the FDA and all their negativity and hatred for this Co. Amrin, which everyone knows..
    11 Oct 2013, 03:53 PM Reply Like
  • Doewap
    , contributor
    Comments (919) | Send Message
     
    Negativity and fear are king in the markets today and I refuse to succumb.
    11 Oct 2013, 04:27 PM Reply Like
  • Scrying Biotech
    , contributor
    Comments (1889) | Send Message
     
    ScryingBiotech ~ Foretell the Future ~ http://seekingalpha.co...
    11 Oct 2013, 03:37 PM Reply Like
  • Doewap
    , contributor
    Comments (919) | Send Message
     
    Scrying, bugger off with this nonsense
    11 Oct 2013, 04:26 PM Reply Like
  • Scrying Biotech
    , contributor
    Comments (1889) | Send Message
     
    Nonsense that has saved investors 5 times this year from losses: Delcath 67%; Aveo 70%; GTX 71%; CYTK 47% and AMRN 22%.

     

    Perhaps you could give us a prediction. It does take courage though. Not for everybody.

     

    I do however like the phrase "bugger off" as it appeals to my British roots.

     

    Always be well...

     

    Michael Webb
    11 Oct 2013, 04:31 PM Reply Like
  • super_investor
    , contributor
    Comment (1) | Send Message
     
    potential trader of the equity.
    11 Oct 2013, 03:42 PM Reply Like
  • Epa
    , contributor
    Comments (24) | Send Message
     
    I can't understand.
    The placebo capsule are the same as Marine's.
    So where is the problem?
    Tx
    11 Oct 2013, 04:26 PM Reply Like
  • Scrying Biotech
    , contributor
    Comments (1889) | Send Message
     
    It has nothing to do with placebo capsules or reason of any kind. http://seekingalpha.co...
    11 Oct 2013, 04:33 PM Reply Like
  • Ross Klosterman
    , contributor
    Comments (118) | Send Message
     
    Really trying to milk those pageviews, huh?
    12 Oct 2013, 12:14 AM Reply Like
  • Scrying Biotech
    , contributor
    Comments (1889) | Send Message
     
    Ross ~ Every penny helps. Could you please move over to your wife's laptop and pull it up and then on to your son's workstation. And then, if you don't mind, I hear that X-Boxes and Wii's have internet access as well and those might count as non-mobile views so please look me up there as well.

     

    Did I forget anything? Oh yeah, you're a real.....joy. Yeah, that's it. Joy.

     

    Take care,

     

    Michael
    12 Oct 2013, 12:23 AM Reply Like
  • Ross Klosterman
    , contributor
    Comments (118) | Send Message
     
    Just saying... As an avid SA reader more than writer, I have read most of your articles. Unlike many people here, I don't necessarily write someone off based on his or her articles/comments (unless truly bad articles, which in my humble opinion does not apply to you). I enjoy digesting all points of view as well as debating one way or another. You do have some good articles - I did enjoy the more behavioral focused AMRN article you authored, although I disagree with its premise in regards to trading this stock.

     

    Then I went yesterday and read all of the articles that came out and notice that you basically spam your article link in the comments section - the creme de la creme being here, "ScryingBiotech ~ Foretell the Future ~ http://seekingalpha.co..." Foretell the future? That's your investing philosophy and credo to attract followers? Sorry sir but for gaining pageviews in the "now" you have subsequently lost multiple future pageviews from not only me but I'd hazard a guess quite a few other folks as well.

     

    Good luck to you in the future!
    12 Oct 2013, 10:50 AM Reply Like
  • Scrying Biotech
    , contributor
    Comments (1889) | Send Message
     
    Ross ~ You have an excellent point. Everyone who takes a position on a stock makes a prediction in some form or another. I'll admit that after having suffered a deluge of criticism regarding my last whimsical article on Amarin, I was happy to see the premise of that article justified. When news broke that confirmed that premise, I then went out and let everyone know as often as I possibly could. That's an unfortunate consequence of a person who had their worth and confidence stolen from them early in life being excessively exuberant now in their celebration. My apologies to all. I forget that the people who are watching me jump up and down are the very same who are now upset at their loss and feeling a bit awkward about their past defensiveness.

     

    In point of fact, I have little to celebrate in that I get my predictive abilities not from my conscious analytical mind which does play a role, but rather from my amazing, loving and sometimes overly protective guides who are messengers running reconnaissance for me. You see, I'm doing something totally different from anyone on this site. And I don't care one single bit if I have one follower or one hundred thousand.

     

    In fact, I encourage all of my followers now to hit the "UNFOLLOW" button. I don't want in any way to be responsible for anyone's decision making process. The word "follow" implies that to be the case. Perhaps we should rename it the "MUSE" button. I like that much better.

     

    What I do want is the ability to use the gifts that I've been given to place a little wonder into this world, to give people a slightly different perspective that allows them to endure loss without regret or panic, and to celebrate their wins with complete joy. If I can accomplish this, then I've moved forward in my own progression quite nicely.

     

    Now, if it's true that you disagreed with that premise in regards to trading the stock laid out in my last article, then you lost a considerable sum of money yesterday. No big. I believe you'll get it back - or rather hope you will. My reading suggests a combative adcomm followed by qualified recommendation for approval followed by a shocking delay by FDA in December. This will allow for the stock to run up to $12 or so by then.

     

    Thank you for the criticism. You've pointed out a weakness that cuts to the quick of my personality and regrettably always will. Something this broken can only be fixed after transition to the next life.

     

    In the meantime however, I intend to use the best of what's been left in its vacuum - an uncanny ability to avoid disaster and pick winners.

     

    That's what I do.

     

    Michael Webb
    12 Oct 2013, 04:57 PM Reply Like
  • 2puttwo
    , contributor
    Comments (571) | Send Message
     
    Anybody buying Monday? Just asking. I really like the stock, not sure about the company.
    11 Oct 2013, 11:44 PM Reply Like
  • Ali Gaytor
    , contributor
    Comment (1) | Send Message
     
    My reading of the document is that there is a relatively minor technical peculiarity in the data that the FDA wants to make sure is only that. Keep your heads people, the sky is not in fact falling.
    13 Oct 2013, 09:28 AM Reply Like
  • ajbrzoz
    , contributor
    Comments (46) | Send Message
     
    It was going to fall today, whether the doc's were good or bad. In this case, the briefing doc's are very good for AMRN's case for Vascepa's ANCHOR indication journey. Case in point, here's the last paragraph in Section 6 Conclusion, pp 103-104, "Patients who are at high risk for CVD who are taking statin therapy and have persistently high TGs are at-risk and need a safe and effective therapy that can be added to their statin therapy for more aggressive and comprehensive lipid control. If approved, Vascepa would fill an important unmet medical need for these patients."
    AdCom vote will be unanimous in favor of.
    13 Oct 2013, 09:31 AM Reply Like
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