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Amarin Corporation plc Message Board

  • frankposting frankposting Oct 31, 2013 1:28 PM Flag

    Oct 16 AdCom Is Invalid

    The invalidation is due to that FDA employed censored data and an inductive voting question (the solo voting question) to lure 9 NO 2 YES from the AdCom. If I can have a transcript of the AdCom meeting, I can show it in details.

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    • You'll find the transcript on the site epadruginitiativedotcom/

    • Frank,

      It appears you are not alone in this as SR last post on ST is as follows:

      $AMRN FDA may have rescinded SPA due to breaking protocol by leaving out material data related to voting question (safety)

      Frank very nice find keep up the great work

      Sentiment: Strong Buy

    • Frank was it Kole or yourself the mentioned data mining at the FDA? This is the same thing claim by Mela Sciences in regards to their BD.

    • Instead of coming up with conspiracy theories and petitions read this below and look in the mirror. Nobody put a gun to our head to invest here. Sometimes admitting a mistake and moving on is the best course of action instead of going down with the ship:

      Make sure management is competent and continually reevaluate this. If there are any doubts, get out! Management is one of the most important things to a biotech.
      Insider stock sales are extremely important. Money talks.
      Poor management decisions can haunt the company for a long time. Be wary on extravagant management claims.
      People who make poor decisions usually make more poor decisions. Poor decisions also breed more poor decisions.
      Valuation matters. AMRN had a market cap of a few billion without even selling a single dose of Vascepa.
      Don't be afraid to take a small loss to avoid a larger one down the road. Don't keep a loser just because you are down big and you think it might come back. If the facts change, change your investment thesis.
      Don't get married to the stock. Don't get caught up in the hype. You need to be able to look at the stock objectively and make decisions based on logic and facts.
      Follow the volume. The folks trading heavy volume are usually the most informed. After the briefing Friday it traded 40MM shares or so. There was definitely something wrong.
      Don't buy into the claims that shorts are just driving the price down for fun. Shorts are some of the most informed investors. They have to be, especially in biotechs where large upside pops are not uncommon. Their profit is capped at 100% with an unlimited downside. Shorts typically do the most research on their stock choices. Look at the Muddy Waters Chinese fraud cases.
      Don't automatically discount Adam Feuerstein because you think he works for the shorts. Maybe he does, maybe he doesn't...I don't know, but it appears that he knows his stuff when it comes to biotechs. That being said, he is by no means the biotech god and I have seen him get things wrong. He called the AMRN FDA panel result. His live blog coverage of the panel was rather balanced. He is one of the reasons I sold on Briefing Doc Friday (thanks Adam). Use his twitter account for an additional resource of information.
      Analyst estimates and price targets are a joke. Most of them appear to have no clue and are usually unreasonable optimists.

    • This is interesting, and we all appreciate everybody's input. However, an earnest general comment to all...

      Observations like this need to be backed up so that they are presented with a rigorous and verifiable discussion. In addition, they need to be "packaged" so that they are "ready to go" to AMRN, FDA or whomever. Just posting stuff here does not get the job done, especially as this effort is still lacking focus.

      • 2 Replies to koleminer1
      • Kol,
        as Frank said we need the ADCom meeting transcript, without it we can't move forward.
        I followed the meeting but hardly understood a word (and the real time trsnscript was a mess) so I cannot help, but some willing and kean native american-english speaking here maybe could do it.
        Hope we find one, because a written documentation of what has been said at the meeting is strongly needed.

      • I believe that the issues are much clear than the days immediately followed Oct 16, and the focus is gradually on. Just need a committee-like group to put it together and seek a workable strategy. For someone/group standing up, better to form a private website. But the public forum as YMB and iHub
        are still too important to be not ignored. However, act fast is a must -- timing is everything. Unfortunately, I am limited by some personal reasons.

    • Suing FDA's malpractice in ANCHOR case and invalidating Oct 16 AdCom should be within current proposal of coming Class Action.

    • Frank,
      where can we find the trascript? Is any entity supposed to provide it? And when?
      One thing more: i think that Joe resignation (they are due at this point, having done so many mistakes) would help a lot both the share price and the negotiations with FDA and eventually for a BO.
      Hope you'll ppost your comment.

    • A glass-root movement is in forming. Long live, American Spirit!

      • 1 Reply to frankposting
      • Frank, i listened to the adcom .... without a doubt the panel was steered towards a negative vote ... clearly something happened along the way that the retailers are/were unaware of ... if reduce it was indeed necessary for approval in december then most of us would have made different decisions... i owned 50k shares going into adcom .... some had 500k shares .. so collectively we are not stupid we didn't no the goalposts were going to be moved after the ball was in the air.... this would be a great 60 minutes episode

 
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