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Amarin Corporation plc Message Board

  • ajax133 ajax133 Mar 1, 2013 3:35 PM Flag

    'PRESUMPTION OF FAVORABILITY

    I remind all the posters on this site of what the precedence is for receiving an NCE. The
    only situations that are comparable to AMRN's, are the Insulins, Heparins, and Low Molecular Weight
    Heparins. There are at least 14 NCE's that FDA has awarded to Co's with competing drugs
    in the above mentioned classes. They all received NCE's inspite of Prior Art being listed in the Orange Book.
    The rational sited as Precedent by FDA is " the preumption of favorability" Check FDA website for information.
    I believe that an NCE in AMRN's situation is predicated on Anchor approval for Mixed Dyslipedemia. NCE's are usually awarded with an approval of a drug. Check Novo Nordisk, Momenta, and Lilly. The run rate
    for Vascepa is running ahead of Lovaza's initial launch. The drug did $1.5B at peak !!! With a vastly superior
    product I can't envision AMRN doing less at peak sales for only the Marine indication. The game changer
    is approval for the Anchor indication. I have been informed by the largest Patent Law Firm located in Northen Ca. that since Lovaza is not listed in the OB for Mixed Dyslipidemia, (no prior art) the presumption of favorabity rational would give the FDA Legal Team cover should GSK threaten litigation. Yes I am in the business and long AMRN

    Sentiment: Strong Buy

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AMRN
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