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Amarin Corporation plc Message Board

williams4076 18 posts  |  Last Activity: Nov 17, 2014 11:17 AM Member since: Dec 23, 1999
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  • 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

  • williams4076 williams4076 Oct 13, 2014 11:44 AM Flag

    Yes, you should first inform the FDA of this and your congressional members. Let the company live.

  • williams4076 by williams4076 Oct 13, 2014 10:20 AM Flag

    This should be the only focus.

  • williams4076 by williams4076 Oct 9, 2014 7:15 PM Flag

    Small Bio will miss you

  • Reply to

    From Washington Post

    by cyliu1222 Oct 9, 2014 4:44 PM
    williams4076 williams4076 Oct 9, 2014 7:13 PM Flag

    RIP Eric, Perhaps DNDN had a pipeline cure for you...maybe in the next life
    BB

  • williams4076 by williams4076 Sep 22, 2014 10:19 AM Flag

    Delay from Senate HELP committee may be due to Lobbyist from AZN contributing money to the two Dem ranking members of the Senate HELP Committee. They are the only two on the AZN take.

  • Reply to

    Federal Judge prepares to kick the FDA

    by williams4076 Sep 4, 2014 12:14 PM
    williams4076 williams4076 Sep 7, 2014 2:11 PM Flag

    "Opting to not orally argue at a hearing and submitting on the briefs is no indication (ZERO) of the merits of the case."

    I agree with you...except the FDA has no Merits to argue, Amarin has showed the FDA has played both sides of the fence. In 2009 it's definitely a NCE only to wax and wane after Marine and Anchor SPA's where successful...In addtion the FDA flat out denied the new NME/NCE policy it released the day after it's ruling on Amarin...

    There's little doubt the FDA was "arbitrary and capricious", the Judge doesn't need to hear oral arguements but she does have to decide how far she wants to push her judgement.

    IMO Amarin was calling attention to this ruling before Jenkins finalizes the FDA position on SPA rescinding.

    The FDA has currently enacted a few new policy's related to NDA considered NCE, they are posted as new MAPPs at the FDA. One interesting change I would like to point out: NCE decisions have been moved to the priority list and up in the level they are decided. Also, There's a post approval review interview with an "outside company", interviewing both the company and the review team.

    IMO Jenkins will also "rule" on NCE related to this new policy and perhapse our approval date will start at the date of the new policy 8-28-2014. Just hoping:) But the FDA needs a serious makeup call to put Amarin back on track to a justfied Marketshare.

    Thanks for your opinion,

    Williams/BB

  • Today, NCE suit updated;
    Simply an action by Amarin to highlight this is still open, wide open. The FDA doesn't want to argue in open court about this issue.

    IMO FDA is actively attempting to negotiate SPA terms that are not up for negotiation. It's a SPA, Amarin fulfilled it's terms, the FDA broke the contract and materially damaged Amarin and stakeholders. In addition, the FDA ignored it's mission and withheld a safe effective treatment currently the NLA is proposing is a serious health risk for CVD and stroke risks.

    " Notice of Availability for Oral Argument
    The Court has pending before it the parties's cross-motions for summary judgement. Amarin has requested oral argument on it's motion. See L. Civ.R. 7(g). Defendants take the position that the motions can be decided without oral argument.

    The parties have conferred regarding counsel's availability for oral argument and respectfully propose the following dates in the event that the Court elects to hear oral argument:
    Monday Oct 27
    Wednesday Oct 29
    Thursday Oct 30"

    The FDA is playing a very dangerous game with the wrong group of stakeholders.

  • williams4076 williams4076 Sep 4, 2014 9:18 AM Flag

    Does nothing to assure FDA abides to REDUCEIT SPA...the FDA is arbitrary and capricious...nothing stops them from moving the bar. This is the point of SPA's, Congress needs to fix the FDA.

AMRN
1.26+0.040(+3.28%)Nov 26 4:00 PMEST

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