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Amarin Corporation plc Message Board

  • brandonuk03 brandonuk03 Jul 30, 2012 10:50 PM Flag

    Now 4 legitimate concerns

    1) NCE still a toss up

    2) AMRN may take this drug to market alone. Why sell shares in a buyout was looking likely or management was confident of a buyout?

    3) Insider selling. How about Joe set an automatic sell on August 17th? and again 3 months from now?

    4) Where is patent 889'? Reasons for allowance was a month ago.

    There will be blood in the streets tomorrow. Mark my word. Management screwed all the longs this week.

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    • Yeah, I've read and posted that before. I'd like to know the specific precedence he is referring to in the first post. I'm a pharmacist and I'm not sure what that might be. I agree, NCE arguments are made on both sides of the fence. Personally when John Theron sells 9 days before a scheduled meeting with the FDA, I'm selling too.

      My advice for anyone holding AMRN through NCE is to lighten your position and lower the risk now. You can always buy again later.

    • Here's the CEO's argument for exclusivity, market protecction, and NCE from a Jan 3 2012 letter to shareholders:

      In the United States, we believe that there are strong arguments for AMR101 to be awarded FDA five-year new chemical entity (NCE) marketing exclusivity. We expect the FDA determination on NCE exclusivity will be made in connection with an NDA approval, and cannot assure you that we will be granted NCE exclusivity. Our optimism for NCE exclusivity is based on the following factors: First, there is precedent at FDA for granting NCE status to a previously uncharacterized active moiety that was part of a previously approved product. Second, the FDA required Amarin to conduct non-clinical and clinical work consistent with the characterization of a new active moiety and approval of an NCE product. The only other omega-3 based product approved by the FDA is Lovaza™; however, we believe the active moiety in Lovaza and the active moiety in AMR101 are different, which we believe is reflected in the decision to establish different molecular family names for icosapent ethyl (AMR101) and omega-3 acid ethyl esters (Lovaza). The eicosapentaenoic acid (EPA) in Lovaza represents less than half of Lovaza and we believe the EPA in Lovaza was not required to be separately characterized as an active moiety in Lovaza. Additionally, Amarin also plans to seek regulatory exclusivity for AMR101 in Europe and we believe that the lack of regulatory guidelines in the United States and Europe for establishing bioequivalence for generic forms of this type of molecule may provide us with added exclusivity protection.

      In addition, we believe the market position of AMR101 may be further protected through a combination of long-term manufacturing agreements with qualified global suppliers and technically advanced product specifications for which key manufacturing methods and analytics are protected through trade secrets or potentially protected through manufacturing patent applications being pursued by our suppliers.

    • Can you recap why you believe NCE will be awarded?

    • Thanks for recognizing the concerns that most of other longs seem to want to ignore. I'm up for a good debate and don't mind people questioning my opinion, but don't call me a basher. I may get back in AMRN, but at a much smaller position. Will watch closely over the next few weeks.

    • 1) NCE still a toss up -
      Toss up? says who? try strong probability.

      2) AMRN may take this drug to market alone. Why sell shares in a buyout was looking likely or management was confident of a buyout?

      Pre programmed sells or maybe they anticipated the bear raid? Some think it was obvious - maybe they are smart traders too.

      3) Insider selling. How about Joe set an automatic sell on August 17th? and again 3 months from now?

      That is number two no double counting.

      4) Where is patent 889'? Reasons for allowance was a month ago.

      Wait and see.

      • 2 Replies to l0tsaluck2000
      • Go look at the package labeling for Lovaza and Vascepa. You'll find the same chemical structure, chemcial formula and molecular weight list in the label. How is it NCE? If anyone can find evidence to refute that it's a sure thing, please fill in everyone else, but I this is a loaded questions as I know the information is not out there. If you listened to the conference call you'll see that management said they didn't expect NCE to be announced with FDA approval.

        I sold last night at $12.71. You guys can bash me all day, but I mitigated what I knew would be more of a loss today. I believe Vascepa is a great drug, but management is ruining shareholder value. I may be back in AMRN eventually, but right now my confidence in the company is at an all-time low.

    • I find those concerns legitimate. The insider sales, well we're stuck with that one and the other 3 are yet to be resolved. Either way, they all pressure the stock.
      I do not care for the fact that anyone who brings up concerns is called a basher.

    • Your new found fear won't wash with me. If you really had a clue about this stock and knew what was going on you wouldn't have posted this. Don't be taken in by the circus. Enough said.

    • Brandon, I admire your ability to be honest in the face of a lynch mob of longs who want to crucify anyone who is not pumping sunshine about the stock. I think 1 and 2 are the legitimate concerns I have too, coupled with the quantity and value of the insider selling post approval. My concern has been that they'll need to get the expanded label before most buyers will be ready to pull the trigger at a good price, and they'll need the patents in place too. Seems like a buyout is still a year to a year and a half away before being realistic, based on historical precedent. Ultimately the science and the drug is a winner, but there are still a number of unknowns and work left to do, and they appear to be headed down a path to go it alone. No partnership announcements in secondary markets, no revenue generation, and another year or longer of preparation and then we may be talking secondary offering. Seems like the stock price is destined to take a dip for awhile until the expanded label and sales, and or public offer drives up the stock price.

      • 1 Reply to davidjmeyermha
      • David

        IMHO -- Vascepa will have to big an impact on the Lipid disorder market to be left alone that long.

        If you read the posts of patients such as myself , and doctors and Cardiologists that post here --you would understand that a major shift in treating Lipid disorders is about to take place .

        Big Pharma is unlikely to leave this untouched once NCE and patent issues have been resolved .


    • Brandon

      You know what Roshchild said about "blood in the streets " ---- "Time to buy"


    • number 2-
      Automatic sale for Joe adopted in May.
      You sell some shares because Drug was not approved yet and was a fair expectation of a nice pop post PDUFA,which unfortuna tely didnt occur..
      As for buyout, for all we know,negotiations didnt start to heat up until last Friday, day after approval..

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