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david22hughes

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  • Will Cardiovascular Concerns Jeopardize Amarin's Upcoming FDA Advisory Panel? [View article]
    Read the question being asked again:

    "Taking into account the described efficacy and safety data for Vascepa, do you believe that its effects on the described lipid/lipoprotein parameters are sufficient to grant approval for co-administration with statin therapy for the treatment of patients with mixed dyslipidemia and CHD or CHD risk equivalent prior to the completion of REDUCE-IT?"

    Here's a summary of Vascepa's main effects:

    "After 12 weeks of therapy, statistically significant differences were observed between placebo and AMR101 4g with respect to TG (-21.5%; p<0.0001) and with respect to secondary endpoints such as LDL-C (-6.2%; p=0.007) and non-HDL-C (-13.6%;p=0.0001)."

    A statistically significant reduction in TG's ALONE should be considered enough as that was the agreed upon primary endpoint of the ANCHOR trial. What incentive do pharmaceutical companies have to spend hundreds of millions of $'s conducting clinical trials if the FDA then moves the goalposts come ADCOM, PDUFA time? When combined with the secondary endpoint reductions in LDL-C and non-HDL-C along with all the other favourable lipid parameters, Vascepa clearly meets all the criteria necessary for it to be granted approval.

    From Page 8 of the ADCOM document (and repeated word for word again on page 63):

    "In considering the results of the ANCHOR trial, the presumption has been that improving various lipid parameters will translate into a reduction in cardiovascular risk. With rare exception, FDA has historically considered granting approval for lipid-altering drugs based on favorable changes in the lipid profile, with the assumption that these changes would translate into a benefit on clinical outcomes."

    REDUCE-IT, once complete, will finally back-up the assumptions, but at this time it is NOT required for ANCHOR approval.

    From page 87:

    "The applicant-sponsored cardiovascular outcomes trial, REDUCE-IT, which is studying patients at high-risk for cardiovascular disease at LDL-C goal on statin therapy with residually high triglycerides (TG ≥200 mg/dL to <500mg/dL), intends to confirm this implied benefit."

    Vascepa is safe, efficacious and has implied CHD benefit. It's as simple as that. Everything else is smoke and mirrors.
    Oct 15 05:18 AM | 15 Likes Like |Link to Comment
  • All Amarin Eyes On Sunday's Prescription Data [View article]
    So Fartstain, what exactly is your reasoning behind your assertion that the FDA will NOT approve Vascepa for the ANCHOR indication?

    ".......because Amarin lacks clinical data demonstrating a cardiovascular benefit for its prescription-grade fish oil in this mixed dyslipidemia population. There is no urgent or unmet medical need for these people, but there is considerable doubt raised by recent published studies showing fish oil does nothing to reduce death, heart attacks or strokes."

    "lacks clinical data"? Have you even read the ANCHOR result data????

    "no urgent or unmet medical need for these people"????

    Heart disease is the #1 global killer. You are aware of the JELIS study and Vascepa's sister product EPADEL? Wouldnt you say that data bodes very well for Vascepa? "In addition, in an outcomes study called the Japan EPA Lipid Intervention Study, or JELIS study, which study consisted of more than 18,000 patients followed over multiple years, Epadel, when used in conjunction with statins, was shown to reduce cardiovascular events by 19% compared to the use of statins alone. In this study, cardiovascular events decreased by approximately 53% compared to statins alone in the subset of patients with triglyceride levels of ³ 150 mg/dL (average 269 mg/dL at entry) and HDL-C <40 mg/dL."

    ".... there is considerable doubt raised by recent published studies showing fish oil does nothing to reduce death, heart attacks or strokes"

    So all fish oil is the same regardless of EPA/DHA concentration and purity? You are absolutely clueless and statements like that do nothing other than demonstrate your scientific illiteracy.
    May 25 03:21 AM | 10 Likes Like |Link to Comment
  • FDA Rescinds Amarin's ANCHOR Study Special Protocol Assessment Agreement [View article]
    The FDA previously denied GSK's application for Lovaza to expand into the estimated 36 million patient population with high triglycerides in the 200-499 mg/DL range citing concerns about the fact it raised LDL by 49%. That was a legitimate reason. Lovaza has an a-fib warning in addition to that. Vascepa works just as well as Lovaza at lowering triglyerides but actually reduces LDL cholesterol and has no a-fib safety concerns. Vascepa met all primary, secondary and safety endpoints as per the agreed upon SPA set by the FDA. The FDA has now officially binned the SPA.

    The question is why, what is their reasoning? Anyone who thinks it has anything to do with results from the ACCORD-Lipid and AIM-HIGH and the HPS2-THRIVE outcome trials is seriously deluded. That's just the cover story.

    There has been obvious manipulation of the Amarin share price going on. This may be an outright attempt to try and bury the company as the FDA, hedge funds and GSK collude together to wipe Amarin out, or, it may be because big pharma want to get this drug on the cheap by returning the big fat finger JZ showed to them. Something is going on behind the scenes that we are not privy to and Amarin have clearly been warned about keeping stum.

    There is huge potential for this drug but NOT when marketed as a fish oil alone. The FDA are making that clear based on their ridiculous logic. It could still be prescribed and marketed in combo with a statin like Lipitor but only big pharma would be allowed do that which means Amarin will have to sell up shop post ANCHOR denial. The writing is on the wall.

    The next conference call on November 7th will be amusing.
    Oct 30 03:19 AM | 8 Likes Like |Link to Comment
  • FDA Rescinds Amarin's ANCHOR Study Special Protocol Assessment Agreement [View article]
    The whole point of conducting the REDUCE-IT trial was so that ANCHOR would get approval for the expanded indication, allowing Amarin to continue its future funding by tapping into a multi billion $ market. Why waste everyones time and money agreeing to an SPA that you had no intention of adhering to? Why tell a company they need to have an outcomes study 50% enrolled before acceptance of the sNDA only then later, subsequent to a farcical ADCOM, to tell them to go stuff themselves? It's a total shit show.

    Prescriptions? Everything Amarin had been doing up until now was in preparation for the expanded label in January. Why you think they only had 275 reps and took out that $100m loan that starts looking horrible after Q1 2014 without ANCHOR?

    Shenanigans I tells ya. Pfizer or GSK buy this in Q1 2014 for mere buttons.
    Oct 30 06:29 AM | 7 Likes Like |Link to Comment
  • Amarin's Naysayers: Much Ado About Nothing [View article]
    Management has stated on numerous occassions that they will not attempt to market the ANCHOR indication alone.

    They get approval for the ANCHOR indcation and then NCE and will be bought out by big pharma. THE END.
    Jun 24 08:24 AM | 7 Likes Like |Link to Comment
  • Risky Amarin Sets Its Cash Pile On Fire [View article]
    What's all this crap about a slow launch?? JZ said in the call that right now they are "3-6 months ahead of where they expected to be" at this time. That's a huge statement. Was anyone listening??? I didnt hear any mention of it from the Fartmaster or his gimp Quoth from the peanut gallery. Funny that.

    I just listened to the Q&A again and that dude asking him about ANCHOR. JZ COULD NOT have been more coy if he tried when talking about ANCHOR. Go back and listen to his tone and how he is being uber careful about what he says. It's blatently obvious they will be taken over once ANCHOR is approved and I have a sneaky feeling it could happen well before December 20th.

    Nice sales in the 2nd quarter now, positive NCE determination, a few more patents in the bag, combo data announced in the next few weeks, sNDA approval before December and its game set and match Amarin by the end of the year. They can easily get an offer of $40+. Expect a big pharma bidding war.
    May 10 11:30 AM | 7 Likes Like |Link to Comment
  • Analysis of Vascepa's FDA Briefing Documents [View article]
    So the ADCOM is apparently not just about the shoe in that is the ANCHOR indication (10X the size of the currently approved MARINE indication) -such a ridiculously easy decision to approve it that it barely merits discussing at all- it is also about whether or not to include labeling language for the REDUCE-IT patient population before results are known:

    "Taking into account the described efficacy and safety data for Vascepa, do you believe that its effects on the described lipid/lipoprotein parameters are sufficient to grant approval for co-administration with statin therapy for the treatment of patients with mixed dyslipidemia and CHD or CHD risk equivalent prior to the
    completion of REDUCE-IT?"

    Well now, "taking into account the described efficacy and safety data for Vascepa" based on all the available evidence, you would have to conclude that yes, "its effects on the described lipid/lipoprotein parameters ARE sufficient to grant approval for co-administration with statin therapy for the treatment of patients with mixed dyslipidemia and CHD or CHD risk equivalent prior to the completion of REDUCE-IT".

    A reminder to all that the REDUCE-IT patient population is about twice the size of MARINE and ANCHOR combined ie >$10 billion/year.
    Oct 14 06:39 AM | 6 Likes Like |Link to Comment
  • All Amarin Eyes On Sunday's Prescription Data [View article]
    @ the dumb Fartstain and all the other dumb ass shorts and weak longs who havent done their homework and/or are scientifically illiterate and/or are intellectually challenged

    Some questions for you to consider:

    1. Did Vascepa (AMR101) meet its primary endpoints in the Phase 3 trial for the ANCHOR indication?

    2. Is the ANCHOR indication supported by an SPA agreement with the FDA?

    3. Was there any serious adverse events in the Phase 3 trial for the ANCHOR indication?

    4. What guidlines has the FDA given Amarin regarding the ANCHOR sNDA?

    Some answers for you:

    1. The ANCHOR indication targets patients with high triglycerides between 200-499mg/dL who are also on statin therapy for elevated levels of LDL-C.

    In the 4g dose for the ANCHOR indication, the primary endpoint for the reduction of triglycerides was met; a 21.5% reduction in triglyceride levels was observed. IN ADDITION TO THIS, there was a statistically significant 6.2% decrease in LDL-C levels from baseline. There was also additional favorable results in other important lipid and inflammation biomarkers.

    2. Yes, it is.

    3. In the ANCHOR trial, Vascepa (AMR101) exhibited a safety profile comparable to placebo. There were no treatment-related serious adverse events in the ANCHOR study. No significant changes in fasting blood glucose, hemoglobin A1C, vital signs, electrocardiograms, or liver or kidney function were observed with either AMR101 dose.

    4. To obtain FDA approval of Vascepa (AMR101) for the ANCHOR indication, based on communications with the FDA, Amarin must have first been granted approval for the MARINE indication and be substantially underway with a cardiovascular outcomes study at the time of the submission of an NDA to the FDA for the ANCHOR indication. Based upon feedback from the FDA and consistent with the respective SPAs for the MARINE trial and ANCHOR trial, Amarin does not believe the final results of an outcomes study are required for FDA approval of Vascepa (AMR101) for the ANCHOR indication.

    (The source used for this information is Amarin's 10-K)
    May 25 02:52 AM | 6 Likes Like |Link to Comment
  • Why I'm Adding To My Amarin Short Position [View article]
    I just had a read of one of your other articles:

    http://bit.ly/11Y0Zia

    “The market is a destitute cesspool, full of dirty tricks like market manipulation, naked short selling, cellarboxing stocks, and derivatives.”

    “The financial world is a dark world that exists on backstabbing, complex vocabularies and secret handshakes. These things all occur under the cloak of secrecy in the secret fraternity that is Wall Street, and if you don't have even the least bit of education on the fundamentals going in, you'll never understand the complexities; and your life savings will be systematically bilked from you and will go towards some billionaire's landscaping bill.”

    “95% of the people feeding you advice; whether it's here on Seeking Alpha, on CNBC, or in the Wall Street Journal all have agendas and positions that they're trying to make money on. Believing these people disclose these positions all the time is laughable. Take everything, including what I write, as a sales pitch. Go in as a skeptic and question motives. Again, finance is a lesson in cutthroat 101.”

    Well, i’m learning and it’s all pretty disgusting. The quotes above say it all about the levels of personal integrity needed to be a professional Wall Street crook. You guys would sell your granny to turn a profit if you could. I aint cut out for that particular game but knowledge is never wasted…

    INTEGRITY: 1. adherence to moral and ethical principles; soundness of moral character; honesty.

    Enjoy the weekend.
    Apr 26 03:39 AM | 6 Likes Like |Link to Comment
  • Opko: Ignore The Commentary And Focus On Numbers [View article]
    Does anyone know if Rayaldy is likely to qualify for NCE?

    I find it very difficult to bet against a self made billionaire. At worst I can see the share price doubling from current valuation. Not a bad buy and hold for a while methinks.
    Feb 19 04:39 AM | 5 Likes Like |Link to Comment
  • Can Amarin Salvage Its Earnings Call? [View article]
    Horseshit. None of you FDA supporters can answer me this simple question. I will ask it again. Why did the FDA allow the ANCHOR trial to be run in the first place if lowering trigs in the 200-499mgs/DL range is of no clinical benefit? Why did the FDA then accept the sNDA?
    Nov 5 09:11 AM | 5 Likes Like |Link to Comment
  • Amarin's Counterpunch: What Q2 Earnings Could Mean For The Future [View article]
    The way I see it playing out for what its worth.

    I see a bottom at the current stock price. From here it should climb up towards $9 with Q2 earnings in August and anticipation of the ADCOM hearing in October. A successful hearing sees it jump up over $10 with the approaching December ANCHOR PDUFA then a mere formality.

    Expect NCE decision and an early approval of ANCHOR well before the scheduled December date and the share price to be over $20 by then. Buyout speculation will send it towards $30 and by the end of the year Amarin may be at the center of a bidding war. JZ isnt entertaining offers below $40 with ANCHOR in the bag and the enormous potential of the REDUCE-IT trial (twice the combined market potential of the MARINE and ANCHOR indications).
    Jul 18 10:21 AM | 5 Likes Like |Link to Comment
  • The Future Of Omega-3 Based Lipid Management: All Eyes On Amarin [View article]
    Where's Fartstain???? 45 comments and not a peep from him yet! I think you've scared him off with all the science and facts in your article - he struggles big time with science and facts.
    Jun 1 01:13 AM | 5 Likes Like |Link to Comment
  • Amarin: It's The Strategy, Not The Science [View article]
    Lovaza is a poor man's Vascepa.

    OTC fish oil is a poor man's Lovaza.

    It really is that simple.
    May 20 09:50 AM | 5 Likes Like |Link to Comment
  • Risky Amarin Sets Its Cash Pile On Fire [View article]
    Most of the heavy lifting is now done. How much cash did they say they have left? $200+ million? I'd say Amarin are sitting very pretty right about now and you know it.
    May 10 04:11 AM | 5 Likes Like |Link to Comment
COMMENTS STATS
231 Comments
287 Likes