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hipfreejazz

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  • FDA To Amarin: 'I Said Good Day, Sir!' [View article]
    Would you like to perform some more in-depth analysis? Read Dr. Thomas Ma's citizen petition and dispute his arguments.

    http://1.usa.gov/Ydx1oN;D=FDA-2013-P-1612-0005
    Jan 25 05:10 PM | Likes Like |Link to Comment
  • Analysis of Vascepa's FDA Briefing Documents [View article]
    As indicated in documents cited below, the ANCHOR sNDA requests approval to treat adults with high triglyceride levels who are also on a statin.

    2/28/13 Amarin Form 8-K Page 7:

    "On February 26, 2013, Amarin announced that it submitted a sNDA to the FDA requesting approval to market and sell Vascepa to the patient population studied in the ANCHOR Phase 3 trial, adult patients with high triglyceride levels ( ³ 200 mg/dL and <500 mg/dL) who are also on statin therapy for elevated LDL-C, which we refer to as mixed dyslipidemia."

    http://bit.ly/1gBhDOU

    6/19/13 Amarin Form 8-K Page 7:

    "The proposed ANCHOR indication would expand the Vascepa patient population to include adult patients on statin therapy with triglyceride levels ranging from 200 to 499 mg/dL (and mixed dyslipidemia)."

    http://bit.ly/1gBhCdU
    Oct 14 06:06 PM | Likes Like |Link to Comment
  • Thumbs Down To Amarin's ANCHOR Would Sink Its Ship [View article]
    Danburydude, thanks for the insights but please review the reports released by Amarin pertaining to ANCHOR trial and ANCHOR sNDA.

    As stated on page 7 (11 in Reader) of Amarin's 2012 Annual Report, "ANCHOR trial was a...study in patients with high triglycerides...who were also receiving optimized statin therapy."

    http://bit.ly/1gBhDOS

    As indicated in documents cited below, the ANCHOR sNDA requests approval to treat adults with high triglyceride levels who are also on a statin.

    2/28/13 Amarin Form 8-K Page 7:

    "On February 26, 2013, Amarin announced that it submitted a sNDA to the FDA requesting approval to market and sell Vascepa to the patient population studied in the ANCHOR Phase 3 trial, adult patients with high triglyceride levels ( ³ 200 mg/dL and <500 mg/dL) who are also on statin therapy for elevated LDL-C, which we refer to as mixed dyslipidemia."

    http://bit.ly/1gBhDOU

    6/19/13 Amarin Form 8-K Page 7:

    "The proposed ANCHOR indication would expand the Vascepa patient population to include adult patients on statin therapy with triglyceride levels ranging from 200 to 499 mg/dL (and mixed dyslipidemia)."

    http://bit.ly/1gBhCdU
    Oct 13 07:26 AM | Likes Like |Link to Comment
  • AF Backtracking, AMRN Will Be Approved On Time [View instapost]
    Steven Ketchum's (Amarin's President of Research & Development & SVP) comments during Amarin Corporation's Q2 2013 Earnings Call August 8, 2013:

    "As a reminder, the ANCHOR study was conducted under Special Protocol Assessment Agreement with the FDA.

    This is an extra step that we took with the FDA before commencing the ANCHOR study to ensure that we had a written understanding with the FDA as to what they required for approval of the ANCHOR indication. We believe that we have achieved all that is required. More specifically, we achieved all of the primary and secondary clinical endpoints of the study.

    For clarity, the SPA and corresponding regulatory discussions in no way require us to have the outcome study completed for the sNDA to be accepted for review or for the ANCHOR indication to be approved. We announced in Q1 that over 4,000 patients were enrolled in the REDUCE-IT study and that we submitted the sNDA for the ANCHOR indication. In Q2, the FDA accepted the sNDA for review.

    As is typical, the FDA provided Amarin with a letter that notified us of this acceptance. This Day 74 Letter is in response within 14 days of the initial 60 day review period of the application is commonly used by the agency to preliminarily flag any early and potentially important review issues. The Day 74 Letter for the ANCHOR sNDA included no such surprises. In particular, the letter did not, in any way, suggest that the agency plans to reset its requirements for approval of the ANCHOR indication.

    Some investors have interpreted the AdCom as implying that the agency intends to change the rules for Amarin with respect to the status of the REDUCE-IT outcome study. We have not seen evidence of such a change. We had considerable discussion with the agency over what constituted substantial underway for the outcome study and during these discussions, never did they suggest changing their requirements.

    Rather, we believe that they appreciate the broad undertaking that we are pursuing with REDUCE-IT and the scientific seriousness with which we are conducting the study. At this point, FDA has accepted our sNDA for review, which reflects to us that they agree that the outcome study is substantially underway."
    Sep 26 08:22 AM | 2 Likes Like |Link to Comment
  • SIGNIFICANT AMRN DEVELOPMENT--PT CHANGE [View instapost]
    Agree with most of your points and that Amarin is clearly a valuable asset. However, where does $35 PT come from and where is the analysis to support it? If it's worth more than $8B, is the PT > $50? Claims should be substantiated. Without supporting analysis, you're guessing...
    Jul 17 06:13 PM | Likes Like |Link to Comment
  • SIGNIFICANT AMRN DEVELOPMENT--PT CHANGE [View instapost]
    July 9, 2013 commentary pertaining to Steve Rosenman's "It's All About ANCHOR" instablog:

    Maiwat Comments:

    "Steve, no disrespect intended, but please stop quoting your "sources" and please stop with the $28-32 BO. The info your "sources" have given you has yet to pan out. We've heard AZN, GSK, PFE, etc., etc. Maybe it's true but me thinks these companies will wait until AMRN is on its knees gasping it's final breath before they act. Either that or they will just purchase the patents from the mafia loan sharks when AMRN defaults.

    You do a good job discussing the drug and the market it serves. If you do this, you will go a long way in helping people see the potential. But please leave your prognostications out of your analysis."

    Pirateescapee Comments:

    "Unless you can verify the story, sources and facts, I wouldn't print stuff like this.......not even in a blog."

    Steve Rosenman Response:

    "Just like I've stopped guessing at NCE timing, Im going to stop guessing about what he heck mgt is up to...just sticking with fundamentals of drug and the market it serves."

    Thank you for the patent 669 update but It's been barely a week and you're back to your unsubstantiated price target and buyout talk. I'm long Amarin, see value in the Vascepa asset, and hope for significant price appreciation. However, could you please stick to the fundamentals and provide objective, balanced, and substantiated analysis!

    Thank you
    Jul 16 05:03 PM | Likes Like |Link to Comment
  • It's All About Anchor  [View instapost]
    Steve, please review page 6 of Amarin’s June 2013 investor presentation more closely. The data is based on ”US Adult Population Based on TG levels” and sourced from Datamonitor and Archives of Internal Medicine, 2009;169(6):572-578.

    You stated that “ANCHOR is 2/3 of American population.” As of 2012, according to the United Stated Census Bureau estimate, the American population is 313.9M. Based on your claim, more than 210M (2/3 or 67% of 313.9M) Americans would be in the ANCHOR category.

    I assume that you meant “2/3 of [adult] American population.” If this is the case, then 2/3 or 67% of 223.8M (reference previously cited “U.S. Adult Population Based on TG levels” data) is almost 150M American adults. As clearly documented on page 6 of Amarin’s June 2013 investor presentation, the US adult ANCHOR population is 36M—not210M or 150M.

    If it was more accurate and/or more advantageous for Amarin to cite LP Institute and WHO data, why did Amarin not reference this data? If you are citing LP Institute and WHO data for US adult population, please provide specific figures and references.
    Link to June 2013 Amarin Investor Presentation:

    http://bit.ly/12uZYhu
    Jul 12 04:56 PM | 1 Like Like |Link to Comment
  • It's All About Anchor  [View instapost]
    According to page 6 of the June, 2013 Amarin investor presentation, the US adult population is 223.8M. ANCHOR represents 36M of the US adult population or 16%. ANCHOR is not 2/3 or 67% of the US adult population.

    http://bit.ly/12uZYhu
    Jul 11 10:07 PM | 1 Like Like |Link to Comment
  • Amarin's Naysayers: Much Ado About Nothing [View article]
    From Amarin website FAQ section dated May 28, 2013: "In accordance with our Special Protocol Assessment (SPA) agreement with the FDA for the ANCHOR indication, Amarin was required to have an outcomes study substantially underway in order to submit for approval of the ANCHOR indication. The REDUCE-IT cardiovascular outcomes study is substantially underway. In February 2013, Amarin submitted a supplemental NDA (sNDA) requesting approval of the ANCHOR indication. The FDA accepted that sNDA for review and assigned a PDUFA date of December 20, 2013. The SPA does not require that an outcome study be completed in order for the ANCHOR indication to be approved. As of the date of this update, Amarin has not been informed of any change in the FDA’s agreement on this matter.."

    if FDA wanted REDUCE-IT outcomes study results prior to ANCHOR approval, why not reject the ANCHOR sNDA and inform Amarin that ANCHOR will be considered once REDUCE-IT is complete? For the FDA to accept the ANCHOR sNDA, announce a Dec. 20, 2013 PDUFA, and then at this Dec. session state that it wants REDUCE-IT results is not only counter the SPA but also a complete waste of time and resources for all involved.
    Jun 24 01:43 PM | 9 Likes Like |Link to Comment
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