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Amarin Corporation plc Message Board

  • gods_hand5 gods_hand5 Sep 20, 2013 4:46 PM Flag

    14 months and counting.... FDA can't decide on NCE status????? or won't?????

    Why????? I read it was suppose to be 8/8/12....Month following FDA approval?????

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    • Yes!!!!!

    • To the current FDA, NCE stands for No Completion Ever. Aren't you happy with how the federal government efficiently spends the taxes you pay to them?

      • 2 Replies to mp15shoot
      • No. The federal workers will never go without pay. This Democrat and Republican theatrics over the budget occurs periodically to entertain themselves and the US Press, and cause a disturbance in the skittish stock market. If the federal government is really "shutdown" for a week or 2, the federal government "workers" will get an additional week or 2 of paid vacation weeks since they will still get paid but the Democrat controlled government will tell them to take the week or 2 off so they and the Democrat controlled US Press can post story after story about how those bad Republicans hurt everyone by not immediately agreeing to raise the debt ceiling again and again and again continuously under the Democrat controlled government. Its a game, but in reality a dangerous game since raising the debt ceiling ensures continued printing and dilution of the US dollar, which will eventually ensure the implosion of the US economy.

      • I read that the fed is insolvent and if the debt ceiling is not raised by the Democrats then all the federal workers will go without pay until it is!!!!! Including the FDA?????

    • Their printer is broken.... and they run out of paper.
      Give 'em time.

    • Maybe after that Christmas meeting in December with the FDA they can give the NCE?????

    • In Spring 2012 before Marine approval, AF reported of a rumoured FDA meeting with Amarin management where NCE was likely to be rejected. Queried, Joe Z. diplomatically responded with an undisputed fact: no company which has been required to do an outcome study was ever denied NCE. At Marine approval, insiders sold a considerable number of shares. At a conference call, Joe Z. talked about possible NCE outcomes: approval, delay, rejection. That Joe brought up "delay" as a serious possibility is eerily prescient.

      For the past 6 months, it has become clear that NCE would be tied to the Anchor decision. My conjecture is that AF reported correctly, but that Joe Z. argued to the FDA that they couldn't reasonably expect Amarin to be saddled with an outcome study going out to 2016 without NCE on just the Marine indication, so Joe Z. won a small victory with the FDA agreeing to delay the NCE decision until after the Anchor decision. Does that mean the Anchor decision is a lock? I don't think so, because the FDA's decision to convene an Adcomm panel came unexpectedly. And yet, if the panel votes to delay Anchor approval until REDUCE-IT results in 2016, then Amarin would be in the same position of carrying out the REDUCE-IT outcome trial after their exclusivity expires.

      My guess is that if Anchor is approved, the NCE decision will follow immediately and don't be surprised if it's negative. If Anchor is delayed to 2016, then perhaps the FDA will extend the NCE decision until the December decision on Anchor.

      I'm a strong buy regardless of how it plays out.

      Sentiment: Strong Buy

      • 3 Replies to tuneoutthechatter
      • Tune: In other words, there is the potential that the agency set up the requirements and the agreements to cajol and get that outcomes study started knowing if they delay eventually for more data, then AMRN is in a bind about completing the study?. If the FDA did not throw AMRN a bone up front they wouldn;t have started the current cycling trial---so they did! But now are they going to take it back once they got what they wanted??

        Or the agency could be true to their word with AMRN and approve ANCHOR without waiting for Outcomes data via the current study in some form or level---- otherwise AMRN could have been conned here. We just don;t know? The answer comes at this panel meeting! The NCE comment in relation to ANCHOR versus MARINE is potentially valid---who knows--we are kept in the dark abbout exactly what has been said between agency and AMRN management. We are left with and at the mercy of Joes words and reading between the lines!

        The fact that there is a panel meteing means nothing any outcome here is possible at some level and percxentage of odds! The roster and their philosophies will play a big role---focus on that heavily! Because in the end the FDA specifically picked them (Joe didnt) and they are the conductor of this drug orchestra! And the agency will orchestrate towards exactly what they want with the cover of the advisory meeting--its their brand of politics on drug approvals!

        id be all over this if there weren;t an advisory meeting in place. because there is, I can;t go overboard on shares as I have seen the sorry FDA in action too many times over many years! They can be a snake in the grass!

        JMO

        kutz

        JMO

        kutz

        Sentiment: Hold

      • 14 months is a ridiculous amount of time!!!!! Incompetence or just lack of resources?????

      • My Dad will make us all rich.

    • Vascepa has 30 patents. No one now cares for NCE anymore.

    • That's why i don't trust the FDA with the coming AdCom, something fishy is in the works.It has nothing to do with how good V works, some one doesn't wont Amrn to succeed

 
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