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Amarin Corporation plc Message Board

  • harveyspecter357 harveyspecter357 Apr 24, 2013 4:34 PM Flag

    Ok since many won't stop talking about NCE, here is the NCE case...

    All this NCE talk is really getting annoying. 98% of these boards don't even know what NCE is or it's importance beside what it says on Wikipedia and yet all we see everyday is NCE, NCE, NCE...
    So let's get the first fact out of the way.. Lovaza should have never been given NCE from the start. The ONLY reason Lovaza got NCE status is bc it was the 1st FDA apprvd drug to treat the Marine market, That's it!!
    Facts is no one, Not even the FDA would have thought 5 years later AMRN would come a long with a more purified drug that is safer & more effective. That's where the problem started.. So now the FDA was put in a tough spot of possibly issuing back to back NCE decisions.
    2nd issue was the FDA had to at least wait for Lovaza's NCE status to expire which didn't take place until Sept 2012. By that stage the FDA was already looking to change the terms of the NCE process to protect the FDA from having a situation like this happen again. You need to realize that just like with drug approvals the FDA's main concern is #1 safety of the drug and #2 protecting the FDA.
    If anyone knows how the FDA works you know that they are cut and dry when it comes to a "NO" decision. So the fact is that if the FDA really felt they didn't want to grant NCE for Vascepa they would have said no already.. The FDA does not wait 7 months just to say no. They are clearly looking for the best way to go about it, whether it combines Marine and Anchor together or they give NME for Marine and NCE for Anchor. This part I do not know, bc I am not the FDA.. But I will say this... AMRN is NOT the FDA either, so blaming AMRN for the FDA NCE delays is STUPID on all points..The FDA will decide NCE when the FDA is ready and ONLY when the FDA is ready, NOT when we want and NOT when AMRN wants.. So stop blaming AMRN..
    The fact is AMRN has accomplished, met and exceeded every milestone that AMRN can CONTROL..
    Once the true valuation hits many will miss the boat, bc WS has you focused on the wrong things.

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    • Harvey:

      I'm going to be straightforward with you. I'm sorry, but you got an agenda. It's hard to tell definitely, but you're pretty clever... You know exactly what I mean too. Don't try to come back with some of your nonsense "LOLLOLOLLOLs," "LMFAO," ALL-CAPS words or state that I'm bashing you. Enough of that. Feel free to continue posting here (I have no control over you), but it's not necessary to repeat similar points over and over again, although I do have to admit this NCE post is relatively new.

      "The fact is AMRN has accomplished, met and exceeded every milestone that AMRN can CONTROL..
      Once the true valuation hits many will miss the boat, bc WS has you focused on the wrong things"

      I think everyone who is currently invested in Amarin knows this. I'll go back to a previous thing that I said to you. IF YOU'RE SO CONFIDENT IN AMARIN'S 'RESUME' AND ABILITY TO EXECUTE, THEN WHY CONTINUE POSTING EVERY OTHER DAY ON AMARIN'S FUTURE AND HOW PEOPLE WILL MISS OUT? It's not necessary. We understand your argument. I'm sure you have better things to do anyway, for example: running that "fund"....

      Good luck my friend. No need to reply.

      P.S. Although I'm long, there are still many inherent risks with Amarin's GIA strategy currently. Don't think for a second, that we're safe. We have a long way to go. Too much bullishness=BAD!

      • 1 Reply to ticktockisanass
      • Well put ticktock! Seems like there are quite a few people that are drinking this guys cool aid. It's one thing to be passionate about a stock that you own. But this guy clearly has an agenda when he continues to throw out valuations that he guarantees armn will hit and his latest rant that nce means nothing. Like I said before if he really even owns the stock then he should worry about his own investment and stop preaching to others what they should do with theirs. Especially when the pps declines day after day and he keeps claiming now is the time to buy. There is a reason I have named him Harvey suspect!

    • I had a tough day and I come home and read your post. Thanks for the laugh.....not due to your post but the idiotic responses and your answers to them. I do agree with everything you wrote.

    • Very sound approach about NCE, Harvey! Thanks.

      Sentiment: Strong Buy

    • I agree with your comments and their obvious conclusions. NCE will come, not when we want it but when the FDA decides, enough said.
      Concerning the absurd level of short activity, they will cover when they sense danger and not one moment before. In the meantime, the longs must grin and bare it because it will change in our favor and change dramatically so. Keep up the good work.

      Sentiment: Strong Buy

    • Harvey, give it up!! Nobody is reading your posts.

    • What about with the new FDA MAPP guidelines as of May 1st, I wonder if that will cause us to finally get NCE this month. Haha probably wishful thinking.

      • 1 Reply to butoft
      • It could be a possibility. If you also add the FDA issuing Anchor PDUFA i think tha helps as well. I would say this though. If we don't get NCE in May after MAPP and Anchor acceptance & Pdufa then I would believe that the fDA might wait until anchor approval. Many may think that sucks but that is just my opinion.
        I really don't care what happens with NCE, that's my true feeling. I don't pay attention to it, but I figure if AMRN has a chance of getting NCE soon it is in May. (only bc of MAPP n Anchor sNDA & Pdufa) Otherwise who knows.. Only the FDA I guess.

    • If the FDA really thinks tis is cut and dry then why haven't they just giving them the nce. You can't have it both ways Harvey. Please tell the shorts and hedgies that nce is not a big deal because they are playing this no decision perfectly in their favor. So yes it is a big deal to longterm shareholders.....Smarten Up!

    • I disagree with some of your posts but I will have to agree with everything you said in this one. I would imagine it has to be decided by the time ANCHOR gets approved for both Marine and Anchor. Harvey, what are your thoughts on a partnership deal for helping us launch Anchor?

      • 1 Reply to butoft
      • I feel that in the Primary Care medical space in a small market like Marine, AMRN is perfectly fine launching on their own. Joe Z is the only CEO to have success in the Tryg space so he knows what he is doing..
        However, the Anchor market is a much different story. It's a huge market and they are the only drug avalible so they are going to wanna launch this drug with as much power as possible. Going into that market they need and will want a partner. 40 mill is a big diff from 4 mill people. LOL
        The other reason why I feel they will 100% acquire a partner or be BO b4 anchor is because both types of Tryg patients (marine & Anchor) technically see the same doctor, so this whole year is basically FREE advertisement and marketing for the ANCHOR market (if you see what I mean by that) so the drug will be pretty well known by doctors.. So if they have BP at that point to back them when they launch Vascepa could come out of the gate like a real BB drug..
        It's not that AMRN does not want to partner, it actually the total opposite, however in 2012 with the drug only apprvd to launch in the Marine market at the time, plus no NCE decision was made yet and they still had to file sNDA for anchor in 2013 it is pretty much impossible for Joe to get a BO price that is except able for what AMRN is really going to be worth.. So I think he did the right thing and waited bc it's all about ANCHOR and Big pharma knows that, Marine is nothing. Now that we are set to enter the Anchor mkt by year end, once we get Combo-statin data and Q1 scripts BP will pay up...
        think of it this way.. Lovaza catured 15% of thier mkt and did $1 bill at PEAK state.. GSK paid $1.7 bill for that..
        Vascepa's mkt with Combo is $100 Bill. So Vascepa yonly needs to capture 1% of thier mkt to do roughly $1 Bill.. If they capture 15% of their mkt like Lovaza inside 5 years its a $10-$15 Bill a year drug..
        I don't think you would sell for AMRN early for $2,$3 Bill..

 
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