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  • Did Justin Bieber And Taylor Swift Really Kill Elizabeth Arden? [View article]
    Solid article, which I would not have even glanced at if headed with a less interesting title.
    Aug 20 10:25 AM | Likes Like |Link to Comment
  • The Doom Of Deflation Over The European Union Horizon [View article]
    2% per year is not really much deflation.

    If you knew the price would be 5% less next year, would you buy a new automobile this year, or nurse your old car along for one more year?

    I would wait.

    And then, next year.... only one more year and I save ANOTHER 5% or maybe 10%. Why buy now? And so on.... Sure, eventually I buy, but only when I must.

    Hey, you don't have to believe me. Read some economic history. That's what has happened in the past. And don't ask me to explain the logic of consumers. The best economists strain to do that.
    Aug 18 06:33 PM | 2 Likes Like |Link to Comment
  • The Doom Of Deflation Over The European Union Horizon [View article]
    Because we haven't seen serious deflation in many countries for several generations and because economic history is not widely taught in schools, many investors are clueless about how bad deflation can be, and how close we came to a deflationary spiral after 2008.

    It's worth explaining one more time what happens in a deflationary spiral. Real goods are constantly decreasing in price, so no one wants to buy anything unless they absolutely must do so. With no buyers, prices drop further. Loans which are guaranteed against real property are called when the price of that property drops below the loan amount, which forces the sale of that property at a loss. Those forced sales further depress prices because there are still no buyers. The potential buyers are still waiting for that bigger bargain next month or next year. Meanwhile, the gross national product falls because of the decreased economic activity, with everyone just waiting on the sidelines. Wages fall with the decreased economic activity, if you can find a job at all. The result is a deflationary depression. Anyone who is cheering for that fate is clueless.
    Aug 18 01:11 PM | 4 Likes Like |Link to Comment
  • Regado Biosciences' Revolixys Kit: Assessing The Risks Of Allergic Reactions [View article]
    Hi, Michael,

    I also enjoy your wriitng. You and I overlap in our positive outlook for NKTR. I enjoyed your AMRN article although I have a pessimistic outlook on that company's future dealings with the FDA.

    CTI
    Aug 18 08:42 AM | Likes Like |Link to Comment
  • Regado Biosciences' Revolixys Kit: Assessing The Risks Of Allergic Reactions [View article]
    Based on what we know so far, as long my physician is prepared with adequate warnings about rare but serious allergic reactions, I would be willing to be treated with Revolixys rather than other anticoagulants.

    If we are going to have advertising for prescription drugs, I suppose that we should have disclosure of the downside. One possible problem with the "boiler plate dire warnings" is that patients might be frightened away from a good drug by very rare side effects. The other possible bad effect could be that patients will become desensitized to the side effect risks, and completely ignore them. I do not know what the best public policy might be.
    Aug 15 03:24 PM | 1 Like Like |Link to Comment
  • Regado Biosciences' Revolixys Kit: Assessing The Risks Of Allergic Reactions [View article]
    I understand that the DSMB has a set of guidelines which define the conditions under which the trial must be halted. I do not think that they have too much discretion in the matter. Ultimately, restarting the trial will depend on the FDA. The FDA definitely will take into consideration the benefits of a treatment when considering risks and serious adverse events.

    Beyond that, I do not want to be too specific in discussing what the FDA will do. Ever since I was blindsided by the FDA's decision to rescind AMRN's SPA, I have been leery to predict what the FDA might do under specific circumstances.

    If the use of Revolixys (aka REG-1) prevents 5 serious bleeding events at the risk of 20 mild to moderate allergic reactions and 2 severe allergic reactions, the tradeoff is favorable in my opinion. (Those numbers are hypothetical, just for the purpose illustration, and should actually be better than that.)

    Perhaps some others will comment on your questions, which are good one.
    Aug 15 03:09 PM | Likes Like |Link to Comment
  • Regado Biosciences' Revolixys Kit: Assessing The Risks Of Allergic Reactions [View article]
    I suspect that you are better informed than some individuals who are interested in RGDO, including some who have recently happened on RGDO while bargain hunting. I have suffered through clinical holds as a long, for example with ONTY. However, I tried to present a dispassionate summary of the Revolixys situation. Thanks for your comment.
    Aug 15 12:44 PM | Likes Like |Link to Comment
  • Endocyte: A Rare Biotech Opportunity With Significant Upside Potential [View article]
    "Endocyte reported that lack of efficacy in the PROCEED trial was driven by unexpectedly good results in the control arm of the trial, whereas the test arm replicated the efficacy that was seen in the previous Phase 2 study."

    And yet, not too long after that result was announced, Merck backed out of its deal with ECYT for the development of vintafolide. I would conclude that Merck was not so convinced that the problem was in the control arm.
    Aug 4 09:40 PM | 1 Like Like |Link to Comment
  • Is Inovio Undervalued After Positive HPV Therapy Results? [View article]
    The viral clearance result was
    Control 14,3%
    Experimental 40.2%
    That is a 280% improvement in viral clearance. So sorry, chap, that you were unable to read the entire press release. Those results are very relevant to the ongoing HIV trials that INO is running.
    http://bit.ly/TmcOwm
    Jul 26 10:53 PM | Likes Like |Link to Comment
  • Is Inovio Undervalued After Positive HPV Therapy Results? [View article]
    I'm not talking about cancer, I'm talking about HIV and Herpes. You have completely missed the significance of the viral clearance result by being so fixated on cancer.
    Jul 25 12:50 PM | 2 Likes Like |Link to Comment
  • Is Inovio Undervalued After Positive HPV Therapy Results? [View article]
    Many have tried, but no one had previously influenced the course of cervical dysplasia this much with a vaccine, either DNA-based or traditional. So, INO has made a significant advance just considering the primary goal of the phase II trial.

    Medical advances are not usually made in giant leaps, but through persistent step-by-step progress. If you were expecting a revenue source from this first phase II trial, you were bound to be disappointed.

    However, in this case, you missed the most significant result, which could turn out to be a major step forward. HPV is one of those viruses that integrates into the human genome and is very difficult to remove. In the control, only 14.3% of the patients were able to clear the virus from the cervix. Leaving the virus behind means bad things can still happen in the future, such as sexual transmission or cancer. In the experimental arm, 2.8x as many patients cleared the virus, leaving 40.2% of patients with the cervix free of detectible virus.

    No one has been able to influence clearance of HPV to such a large extent before this clinical trial. Beyond HPV, we have the bigger challenges of Herpes and HIV, both which are resistant to clearance. The whole medical world was ga-ga for months over the possibility that just one, single child had been cleared of HIV (which sadly proved not to be so). Imagine that just one HIV patients could cleared of HIV through INO technology. Have you any idea what the impact of that advance would be?
    Jul 24 03:21 PM | 2 Likes Like |Link to Comment
  • Is Inovio Undervalued After Positive HPV Therapy Results? [View article]
    The significance of the viral clearance result is difficult to overstate, assuming the yet-to-be published details support the topline results. Consider that HPV integrates into the genome and yet clearance was achieved. No one has ever approached a result this impressive before with HPV. Now, think HIV. Either you have already thought about that connection, or you should be having a 'holy crap' moment right now. What if.....?

    HIV is still a difficult target, but this clearance result moves the cure of HPV-related cervical cancers (most of them) and head & neck cancers from speculative to a reasonable horse race in my books.

    Clearly, the combination of the SynCon technology and electroporation confers an advantage for vaccines not seen before with HPV. Will this advantage translate into immunotherapy for hepatitis B and prostate cancer, currently under investigation under the deal with Roche? I expect so.
    Jul 23 05:43 PM | 7 Likes Like |Link to Comment
  • Amarin: Will The Lamb Of Ireland Bleat Or The Lion Of The People Roar? [View article]
    At very least, the X-axis must have breaks explicitly denoting any discontinuity in it. No self-respecting scientific editor would allow such a plot to be published. To call that plot misleading is the mildest criticism one could apply.
    Jul 22 04:24 PM | 2 Likes Like |Link to Comment
  • Amarin: Will The Lamb Of Ireland Bleat Or The Lion Of The People Roar? [View article]
    One of the more serious scientific issues for AMRN, highlighted in the FDA Briefing Document and discussed at the advisory committee meeting, was the role of the mineral oil placebo, which seemed not to be inert as expected. Baseline values for several lipid markers that have clinical relevance to cardiovascular health seemed to have been negatively impacted by the placebo. Or that is one interpretation of the situation.

    Note that mineral oil is fairly commonly used as a placebo, in quantities sometimes exceeding the 4 gram per day dosage in the ANCHOR trial, without any previous indication of activity. Indeed, the FDA reviewers were unable to find any evidence that mineral oil should affect patient lipid profiles. An alternative explanation was mentioned by these same reviewers, but not fully explored by them.

    This alternative explanation deserves more consideration. Patients enrolled in the ANCHOR clinical trial were allowed to have previously used a number of lipid-altering treatments, including fish oil supplements. A washout period of 4 or 6 weeks was provided in the trial protocol during which the effects of these other treatments could possibly disappear before trial treatment and measurements began. What if that treatment effect was not gone by the time that placebo was started? Then any deterioration in lipid parameters during placebo treatment could be attributed to the continued loss of the previous treatment rather than any effect by the placebo.

    The use of fish oil supplements is quite common. Moreover, a patient with high triglycerides that volunteers for a fish-oil-based study is apparently someone who has an interest in fish oil supplements and is likely to have used them. This patient pool may be enriched with users of these supplements. Unfortunately, the level of previous use of fish oil supplements by recruited patients is not reported in the FDA Briefing Document.

    Was that 4 to 6-week washout period long enough to dissipate any effect of previous fish oil supplements? Levels of fish-derived fatty acids in plasma decrease in a few weeks when fish oil supplements are withdrawn, but several pools of these fatty acids persist in the body. The fish-oil fatty acids become incorporated into the lipids in the cell membrane and are stored in fat throughout the body, thus providing a reserve of these fatty acids that could continue to affect overall lipid metabolism. Red blood cell membranes have been shown to contain elevated levels of these fatty acids from fish supplements with washout periods longer than 6 weeks (1-3). Adipose tissue can continue to release fish-derived fatty acids for months or years (2). One set of researchers make a strong case for an 18-week washout period, or alternate study design, for endpoints that might be affected by altered membrane fatty acid composition (1). These studies should have been cited in the FDA Briefing Document.

    Why postulate a totally new activity for an inert mineral oil placebo? A more plausible explanation of the apparent deterioration of cardio-vascular-related lipid values in the ANCHOR placebo group is the persistent benefit of fish-oil-derived fatty acids. Instead of exaggerating the benefits of Vascepa because of a flawed placebo, the ANCHOR trial underestimated Vascepa’s advantages because of a too-short washout period.

    1. Brown, AJ, Pang, E and Roberts, DCK (1991). Persistant changes in the fatty acid composition of erythrocyte membranes after moderate intake of n-3 polyunsaturated fatty acids: study design implications. Am. J. Clin. Nutr 54: 668-673.
    2. Katan, MB, Deslypere, JP, van Birgelen, APJM, Penders, M and Zegwaard, M (1997). Kinetics of the incorporation of dietary fatty acids into serum cholesteryl esters, erythrocyte membranes and adipose tissue: an 18-month controlled study. J. Lipid Res. 38: 2012-2022.
    3. Cao, J, Schwichtenberg, KA, Hanson, NQ and Tsai, MY (2006) Incorporation and clearance of omega-3 fatty acids in erythrocyte membranes and plasma phospholipids. Clin. Chem. 52: 2265-2272.
    Jul 22 02:48 PM | 2 Likes Like |Link to Comment
  • Is Hyperinflation Possible? [View article]
    Amusing, and true.
    Jul 20 11:17 PM | Likes Like |Link to Comment
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