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Amarin Corporation plc Message Board

williams4076 14 posts  |  Last Activity: Jan 29, 2015 9:28 AM Member since: Dec 23, 1999
  • Reply to

    Being artificially kept above 1 dollar

    by bobobaginz Jan 27, 2015 1:26 PM
    williams4076 williams4076 Jan 29, 2015 9:28 AM Flag

    Agree, it is being kept over a dollar so the HHS doesn't have to write a bigger check than they already are on the hook for.

  • Reply to

    Disappointment

    by dendreonpro Jan 15, 2015 4:45 PM
    williams4076 williams4076 Jan 15, 2015 6:53 PM Flag

    March 2016....More like December 2015, if Amarin longs make it through Dec 2015 without hearing 60 % interim results....then efficacy is tracking 15%...assuming 5.2% event rates

  • williams4076 williams4076 Dec 3, 2014 11:32 AM Flag

    "dropped the appeals process"...the next appeal level is Dr. Janet Woodcock...that's the same level as the Citizen Petition. If she denies the petition likely Amarin picks up the SPA appeal.

  • Another 180 days has passed since the interim "response". Took 13 days to rescind SPA and how many days to answer stakeholders request? If the evidence was strong to rescind SPA this would be an easy decision, but since NO SCIENTIFIC evidence was used...it's complicated.

  • Reply to

    IMPROVE-IT/Anchor sNDA Application

    by dendreonpro Nov 17, 2014 7:43 AM
    williams4076 williams4076 Nov 17, 2014 11:17 AM Flag

    Sums it up Akanz.

  • Reply to

    IMPROVE-IT/Anchor sNDA Application

    by dendreonpro Nov 17, 2014 7:43 AM
    williams4076 williams4076 Nov 17, 2014 11:15 AM Flag

    Merck's IMPROVEIT met primary outcomes. This validates Triglyceride lowering therapy without an increase in LDL. It creates a significant barrier for Mixed Omega's like Lovaza, Generic Lovaza, and Omtryg....as you know Amarin's patents took out Epanova on Friday.

    Williams/BB

  • Not looking good for any drug increasing LDL, this includes Billion dollar Fibrates (In Metabolic dz. Population) & Mixed Omega combos...

    Rapid expansion in sales expected.

  • Amarin's suit against AZN was dismissed without predjudice based on AZN's contentions they have no plans to immedialty launch Epanova. The merits of the claims are enough to be adjudicated. AZN must notify Amarin prior to launch per court order.

    I'd assume dosing a CVOT might be a grey area of the law, but I don't expect AZN will waste anymore time on Omthera. No NCE, no product launch, no CVOT....and most importantly no combination product to extend Crestor's life span.

    I welcome AZN into filing a similar co-marketing agreement like our partners Kowa and perhaps we can together launch AMR 102 before Crestor gets generic pressure 5-2016. Best to hurry, as we should submit NDA by a minimum of 7-2015 for a clean PDUFA cycle.

    Cheers,

    Williams/BB

  • First clue

  • and you want verification...watch the volume.

  • williams4076 by williams4076 Nov 7, 2014 1:25 PM Flag

    This is the bottom.

  • williams4076 by williams4076 Nov 7, 2014 1:23 PM Flag

    In the near future we're likely to see AZN and Amarin settle patent suit out of court.
    Effects:
    1) Flat out gives Amarin's Patents a test
    2) Provides Amarin with cash to pay off debt, increase SOV

    Evidence...PACER 11-7-2014 13 pages of AMRN and AZN agreeing on nothing...except sealing the case and settling.

    Bottom. $0.89

    This is news before it's news:) Your Welcome.

  • IMO this is due to the Judge seeking damages from HHS. Yes damages...the delay in NCE prevented Amarin from being valued and sold. The likely company that was going to purchase Amarin post Marine Approval was AZN. AZN was likely interviewed by the Judge...and this could be the reason why we saw the CP on the same day we saw all the other actions.

    Could be the first time Pharma's been awarded damages from arbitrary and caprious actions....and this doesn't even consider the Actions of SPA Rescinding!

    Good Luck...and God Bless the American Justice System!

    Williams

  • First AZN and AMRN were ordered to sit down and work this out...they where given 3 days by the Judge. Joint form is due 11-7, pre trial conference is 11-14. Judge seems to be confirming you can work this out or go to trial.

    Next, AZN Omthera file CP requesting NCE for Epanova, however, the arguements the present just point out facts in how the FDA errored in NCE for Vascepa and this mistake took 18 months. AZN does very little to make the arguement for NCE for Epanova. IMO Epanove is a new formulation of Lovaza and under the old or new guidance does not qualify for NCE. Both Lovaza and Epanova, reguardless of being EE or FA have the same mixes of DHA and EPA in the blood that at as the active moiety, just different ratios. The mix is the active ingredient. For example, Low Molecular Weight Heparins where and should have been given NCE, but I can't simply take that mix change around the ratios and call it a NCE...it's still Low weight Molecular Heparin. However if I isolate one 7,000 MW Heperin and only 96% 7,000 MW Heparin and do a study to confirm this weight of Heparin has superior actions to the LMW heparin mix, this is a NCE....Vascepa fits this bill. And under either new or old guidance deserves NCE.

    Finally, in Amarin v. FDA NCE...the DOJ has assigned a new Attorney as lead to the case....their 3rd change. More significant than just a change the Attorney is from the Department of Civil Services, responsible for Financial and Medical Fraud. The FDA should have settled when they had the chance...now someone's going to jail...IMO.

    This all went down on 11-3...it seems to all be related....hopefully the FDA gets to the EPADI CP before Amarin gets a delisting notification, or we'll have a whole new set of complaints!

    Williams/BB

AMRN
1.02-0.01(-0.97%)Jan 30 4:00 PMEST

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