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stephenhandal

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  • The Captain Of Amarin's Listless Ship Makes Ready For The Storm [View article]
    Sorry, but I guess I missed your point?
    Sep 20 09:55 PM | Likes Like |Link to Comment
  • Analysis Of Amarin's Offering And Vascepa Update [View article]
    These articles must be very profitable for you.
    Jul 9 12:10 AM | Likes Like |Link to Comment
  • Amarin's Naysayers: Much Ado About Nothing [View article]
    Adam:

    From Amarin's August 10, 2011 press release:

    "An SPA is generally binding upon the FDA unless a substantial scientific issue essential to determining safety or efficacy is identified after the testing begins. However, there can be no assurance that this will be the case. If the FDA does not consider the SPA to be binding, the agency could assert that additional studies or data are required to support a regulatory SUBMISSION."

    The ANCHOR sNDA has already been submitted and accepted by the FDA as well as given a PDUFA date, so how can the FDA now require more data or additional studies since the sNDA has already been submitted per the above statement (If the FDA... regulatory submission)?

    It seems very bold in my view to think that the 'FDA will reject Vascepa for the Anchor ... indication' and that 'there will be no approval in December or earlier.'

    Furthermore, you state '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.'

    When was Amarin ever supposed to show 'cardiovascular benefit' in the ANCHOR indication? Never - that's totally irrelevant except for the fact that you bring in these recent studies which have failed. REDUCE-IT was the study for that. The ANCHOR indication is patients with triglycerides between 200 mg/dL and 500 mg/dL, while REDUCE-IT tested patients with triglycerides of at least 150 mg/dL and at least one cardiovascular risk factor. They're two separate indications that Amarin is trying to get approval for so why would the FDA delay/deny ANCHOR currently and wait until 2016 for REDUCE-IT. It just doesn't make sense. The ANCHOR data is fine so there shouldn't be an issue. They aren't the same indications and need to be differentiated. REDUCE-IT should not doubt require the cardiovascular outcomes data. Lastly, I've heard that 50% of Lovaza's sales consist of off-label use and since ANCHOR would be the first-in class with this indication, I'd have to argue that it's unmet...

    While you argue that the CV outcomes may be a 'pivotal issue' in the upcoming FDA advisory panel, does it actually have any bearing whatsoever on approval? The only requirement under the SPA was to have REDUCE-IT 'substantially underway' in order for Amarin to request ANCHOR approval and submit the sNDA for ANCHOR. Obviously the FDA advisory panel should consider these other fish oil 'studies,' but it shouldn't significantly influence the committee one way or the other.
    Jun 25 02:27 AM | 9 Likes Like |Link to Comment
  • Amarin's Anchor Will Hold As Vascepa's Sails Unfurl [View article]
    I obviously read your disclosure, but in the future, would you consider Amarin as an investment or are you just going to stay away from it?
    Jun 21 03:32 PM | Likes Like |Link to Comment
  • Amarin Is Dead With Or Without ANCHOR [View article]
    At this point, all you, I, and everyone else can do is speculate. We aren't getting the necessary clarity from management about prescriptions, market penetration, doctors acceptance, results from patients on Vascepa, the company's plans for ANCHOR, what's happening with NCE, what's going on with combo data and what they plan to do with that, sales reps and their performance (although we can judge performance to a degree based on prescriptions), more info re: Reduce-it, and most importantly guidance and what the future looks like for Vascepa. Quite a few of these are important questions so at this point, we can do nothing more than wait till the next CC or until news comes out. Management has to do a better job with IR. Overall though, this stock seems to have quite the two sided bullish/bear aspects. Will be interesting to see who wins in the end.
    Jun 21 02:19 AM | 1 Like Like |Link to Comment
  • Amarin: The Bull Argument (Or How I Learned To Stop Worrying And Love Vascepa) [View article]
    First off, good research. Secondly, I don't understand - sorry, but you do or don't have a position in Amarin?

    You state "I’m still bullish but have no position" in one of the comments, but then it states "I am long AMRN" in the disclosures section. If you could clarify, I'd appreciate it. Thanks
    May 1 02:00 AM | Likes Like |Link to Comment
  • Why I'm Adding To My Amarin Short Position [View article]
    I personally think that all this speculation wouldn't be happening if management were more straightforward and less private.
    Apr 22 10:23 PM | 1 Like Like |Link to Comment
  • The Price May Be Increasing For An Amarin Buyout [View article]
    Brandon, I'm not Steve, but I'll say that $30 is possible, but definitely not right now. Once ANCHOR has been approved, scripts and sales have dramatically increased, an NCE decision has been made, Vascepa has penetrated the market, and good combo results have come out. Plus, I don't see any BP paying $30 until Amarin's PPS has gotten back to $15-16. BP need to be able to justify BO premium and 100% is the maximum I see. It's not unrealistic, but it will take some time.
    Apr 19 10:43 PM | Likes Like |Link to Comment
  • Amarin's 'All-In' On Vascepa Makes It A Massive Risk [View article]
    Thanks Jerry. I appreciate it. It's a battleground over there with him and his followers. It's hard to believe that Amarin has a 6 in front of its share price right now. Good luck. I think in the long run we'll be alright, but short-term, it's ugly.
    Mar 26 06:58 PM | Likes Like |Link to Comment
  • Amarin's 'All-In' On Vascepa Makes It A Massive Risk [View article]
    "The Marine launch has little if any bearing on the future of AMRN" - This is a completely false statement. The Marine launch is very important. Right now especially in the next 4-6 months, all that matters is sales. We need to see a rapid script uptake contrary to what you believe. If Amarin doesn't get its act together, then plan for this stock to take even a further beating. Everything else is sideline (combo, NCE and such). If Amarin wants to get acquired or partnered by the ANCHOR indication, then surely larger pharmaceutical companies are watching the launch closely. I can't believe you would say that. Then not to mention, saying that the Marine launch essentially isn't important would totally contradict your previous line of thinking that there would be a BO before 2013. Then you accuse Quoth the Raven of deception - that's wrong. You keep on acting like ANCHOR is the big prize when you were never talking about it previously.
    Mar 26 01:42 PM | 2 Likes Like |Link to Comment
  • Amarin: Is The Trend Still Your Friend? [View article]
    Brian, you may have wanted to wait until next week to publish this because of sales numbers on Monday (possible sample conversion to prescriptions could be starting) and there's the FDA OB update on Friday... I'm not the author though. Good luck.
    Mar 8 06:23 PM | 4 Likes Like |Link to Comment
  • A Top Biotech Stock To Own In 2013 [View article]
    Also, I found a comment under Adam's article (we'll just leave the person who wrote the comment as anonymous) who listed some of Steve's previous calls which I thought were somewhat interesting:

    Oct. 12th 2012: "near 100% chance of near-term buyout. Near term is before 2012 end, specifically 15-30 days or less."

    Nov. 15th 2012: "hearing orange book determination coming this round... hang on folks"

    Nov. 16th 2012: "My views have not changed, NCE, near term BO +$30, and we could hear Monday still on NCE this month"

    Nov. 28th 2012: "I see no signs of salesforce being hired."

    Dec. 11th 2012: "Yazz: all due respect, let's get something straight. I dont cheerlead or pump AMRN."

    I'm not going to criticize Steve, as these comments purely speak for themselves, but as illustrated you can see for yourselves...
    Mar 8 04:43 PM | 1 Like Like |Link to Comment
  • Amarin: Liking This Speculative Stock's Risk-Reward Ratio [View article]
    6799, I just don't think Amarin is "highly risky".. It may be risky, but at this point, quite a bit would half to happen in order to really crash the stock. I am not on the side that the price would go down if we're denied NCE. I'm in the camp that any decision is good. Also, this article is a soft-bash, so that's part of my reasoning.
    Mar 6 11:07 PM | Likes Like |Link to Comment
  • Amarin: Liking This Speculative Stock's Risk-Reward Ratio [View article]
    You refer to Amarin as a "highly risky equity." Would you care to explain more? Sure Amarin is risky, but definitely not any riskier than some of the other biotechs.

    Also, you said you're a non-invasive cardiologist. What kind of procedures do you do and also what types of cholesterol-lowering drugs do you prescribe?
    Mar 6 07:26 PM | 1 Like Like |Link to Comment
  • A Top Biotech Stock To Own In 2013 [View article]
    Steve, I'll admit - you proved me wrong and published your article..

    Now, I'm still wondering though about your comment regarding the partnership. How do you know as a fact that Amarin turned that down? I highly doubt anyone besides the senior management has any idea.
    Mar 6 06:47 PM | Likes Like |Link to Comment
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