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Amarin Corporation plc Message Board

  • kaylawa kaylawa Sep 21, 2012 1:57 PM Flag

    Reduce-IT "substantially underway" status- any updates?

    As we know, now that FDA approval has been granted AMRN only needs the Reduce-It trial to be "substantially underway" for permission to submit a sNDA for the Anchor population (200-499mg/dl for 36 million target population in the US). As of May 15th, they were actively recruiting at all study centers in the US (where the majority of the enrollees will be) and had received study approval from a majority of study countries on the following list:

    New Zealand
    Russian Federation
    South Africa

    My thoughts are that we must be beginning to approach the midpoint enrollment number BUT the definition of "substantially underway" is subject to the FDA's whims and is largely without precedent. Does anyone have further insight into what constitutes "substantially underway"? AMRN and analysts have indicated a possible Q3 or Q4 submission. Thanks!

    Sentiment: Strong Buy

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • "The Japanese, open-label, high-baseline-intake, mainly primary prevention JELIS trial, predominantly in women, failed to replicate the GISSI trial for the outcomes assessed (sudden and cardiac death) even in the secondary prevention subgroup analysis."

      From "Association Between Omega-3 Fatty Acid Supplementation and Risk of Major Cardiovascular Disease EventsA Systematic Review and Meta-analysis"

      JAMA September 12, 2012, Vol 308, No. 10

    • Kay, this is simple from memory, but I believe 50% enrollment is the definition of substantially underway, and the target for NDA submission was 1st qt, 2013 at the earliest.

      Sentiment: Hold

      • 1 Reply to bigpharmaretired
      • Thanks Bigpharma! Just reviewed the Letter to Shareholders and it mentioned the 50% enrollment as well:

        "Looking Ahead-

        In 2012, we will endeavor to continue executing on Amarin's business plan and work to achieve our milestones with the goal of maximizing the value of AMR101. Our 2012 priorities include:

        -NDA approval for the MARINE indication, which we estimate to occur in H2'12
        -Commercial readiness including market preparation to launch AMR101, whether through a strategic partner or directly
        -Patent protection potentially extending AMR101's proprietary position to 2030
        -REDUCE-IT cardiovascular outcomes study substantially underway with 50 percent patient enrollment
        -sNDA submission for the mixed dyslipidemia indication studied in the ANCHOR trial
        -Publication of data from the ANCHOR trial in a prominent peer-reviewed journal
        -Commencement of study of a combination product comprised of AMR101 and a leading statin"

        Sentiment: Strong Buy

    • // site shows the URL for Govt.filings for CLINICALTRIALS.In that OUTCOME is the name

    • Ask Stephen Schultz by sending him an E mail or
      AKANZ is right--they are focussing on certain group of patients.
      If you remember--JUPITER trials--by CRESTOR (ASTRA ZENECA)--very large group initially-but then results in different groups were looked at. One group showed remarkable results.So that data wassubmitted to FDA in 2009 (2 years into 5-6 years study).FDA panel voted with big majority for approval--and it was approved in 2010 by FDA for expanded labeling.
      Sales were 4.5 bil.$ in 2009--shot up to 6.5 bil.$ in 2011.
      OUTCOME trials --based on JELIS trials results--should PROVE that IT is an important Heart drug--not just a drug that lowers Trigyl.

      Sentiment: Strong Buy

    • I called the study center in Wichita because I'm trying to get my dad to take part in the Vascepa study and asked them that very same question but they weren't able to give me an answer.

      Sentiment: Strong Buy

    • Kayla ---all I can report from my contact working on the trial ---is that all is going well .
      Because the interest was high they had narrowed the field to diabetics and those with stents .
      Originally they were interested in using me because of my lipid disorders and lab rat history ---but then emailed back and said no thanks ---you aren't sick enough ( words to that effect )

      Sentiment: Buy

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