Seeking Alpha
View as an RSS Feed

Curve Tech Investing  

View Curve Tech Investing's Comments BY TICKER:
Latest  |  Highest rated
  • Amarin's Case Vs. FDA Will Garner Positive Attention [View article]
    In short, yes, it's the purity... and the patent protection for the preparation and application of that pure substance. Some components of crude or partially purified fish oils actually increase LDL and may increase inflamation.
    Mar 23, 2015. 11:31 PM | Likes Like |Link to Comment
  • Nektar-102 Will Be An Approved Treatment In Metastatic Breast Cancer [View article]
    Sure, and what electric cars need is a battery pack that travels 600 miles on a single charge and then recharges in 10 minutes, but that does not prevent investors from buying shares in Tesla.
    Mar 23, 2015. 10:08 PM | Likes Like |Link to Comment
  • Amarin Argues In Court For Vascepa Exclusivity [View article]
    Everyone would like to have that piece of information, but no one other than the judge knows.
    Mar 23, 2015. 03:21 PM | Likes Like |Link to Comment
  • Nektar-102 Will Be An Approved Treatment In Metastatic Breast Cancer [View article]
    If I knew anyone right now with advanced or metastic breast cancer, I would want her to have NKTR-102 rather than any of the other single treatments. Of that much I am certain.

    The future for NKTR-102 is probably in combination treatments, where its mechanism and relatively moderate side effects will complement some of the more established agents.
    Mar 23, 2015. 03:09 PM | Likes Like |Link to Comment
  • Alcobra: How Good Is The Post Hoc Trial Analysis? [View article]
    This a very ambitious article, and attempts to shed light on a situation in biotech investing where either a large gain or a large loss is possible. I like investing in such situations where I think that I have an edge. All in all, this article is a very good contribution to SA. I hope to see many more like it.

    I agree with you in being critical of the original conduct of the clinical trial and of the original statistical analysis which apparently did not validate the patient selection. Heads should roll, considering the wasted money and effort.

    Nevertheless, I do also have some criticisms of this article, which make up the rest of this comment.

    What you have called 'entry criteria' above are really better known as 'exclusion criteria'.

    From this article, I find it hard understand how treatment effects were scored for this clinical trial. If raters were used, then one would assume that these raters were professionals who would perform a standard assessment for ADHD. Yet, the article speaks about asking the patient to rate the success of the drug treatment. Certainly, some medications, such as in pain reduction, are scored that way. I will find out for myself, but the article could have been clearer on this point.

    With regard to not allowing patients that are not related to a rater, I could imagine a very good reason for that exclusion. Close relatives would see the behavior of the patient outside of the clinic, and have information that would not be available for most of the other patients. Thus, the rater would be tempted to make an efficacy assessment in a different way for a relative than for a patient who was a stranger.

    While you were more concerned about the removal of patients for violations (or using violations as an excuse for removing patients), I am more concerned about removing outliers. Removing two placebo patients as outliers from the analysis had a bigger effect than removing eight patients for violations. In a dataset of this size, one could possibly have one or two three-sigma outliers as part of the normal distribution. Without some other justification, I find this action very suspect and hard to justify.

    Finally, we see that a mean efficacy change of -2.6 is approaching statistical significance. What I would like to know as a potential investor is if that amount of change is clinically significant. How big would the change be for other treatments? Would a teacher in a classroom see much (any?) difference in the behavior of a student that improved by -2.6 points? I have no idea, but I need some sense of that matter before I consider investing.
    Mar 21, 2015. 01:55 PM | Likes Like |Link to Comment
  • Amarin Argues In Court For Vascepa Exclusivity [View article]
    I give the advantage to AMRN in the court case from what we know. I respect the risk in what I don't know. I am long AMRN more because the preponderance of the science is on their side.
    Mar 20, 2015. 10:49 PM | 1 Like Like |Link to Comment
  • Amarin Argues In Court For Vascepa Exclusivity [View article]
    If AMRN is not awarded the five-year exclusivity, then one possible future is that AMRN may need to file suit against one or more companies to defend their patents. In the worst case scenario, AMRN might then need to raise more funds to cover those legal costs as well as to fund the REDUCE-IT trial until the final result is reported.
    Mar 19, 2015. 09:46 PM | Likes Like |Link to Comment
  • Amarin Argues In Court For Vascepa Exclusivity [View article]
    The ruling could come tomorrow or some years from now, or so I am told by individuals with more experience than I have in such matters. The relevant saying here is, "Justice delayed is justice denied".
    Mar 19, 2015. 09:31 PM | 1 Like Like |Link to Comment
  • Amarin Argues In Court For Vascepa Exclusivity [View article]
    The FDA is part of HHS. The head of HHS was named as a party to the complaint.
    Mar 19, 2015. 09:27 PM | Likes Like |Link to Comment
  • Amarin Argues In Court For Vascepa Exclusivity [View article]
    'Held in abeyance' means that the motions will be ignored for the time being while something else is happening. I am not a lawyer, but I am lead to believe that those two motions for summary judgement are almost always part of such cases. If the judge had granted either motion, that would have been the end of the case.
    Mar 19, 2015. 09:24 PM | 1 Like Like |Link to Comment
  • Amarin Argues In Court For Vascepa Exclusivity [View article]
    That petition was not part of the AMRN complaint to the District Court so it did not really fit into this article. That a citizen would petition the FDA on that matter does seem strange. Is anything more known about that petition?
    Mar 19, 2015. 09:17 PM | Likes Like |Link to Comment
  • Amarin Argues In Court For Vascepa Exclusivity [View article]
    No doubt a small company is very vulnerable in ways that a pharmaceutical giant is not. My current belief is that the FDA actions have not been part of some master plan, but were the work of several different actors, each with his or her own motivation. All of those actions just happened to impact AMRN negatively. I could be wrong.
    Mar 18, 2015. 11:09 PM | 3 Likes Like |Link to Comment
  • Amarin Argues In Court For Vascepa Exclusivity [View article]
    I would certainly not limit that comment to the current administration. To some extent, it is all the same House of Cards.
    Mar 18, 2015. 10:59 PM | 5 Likes Like |Link to Comment
  • Amarin Argues In Court For Vascepa Exclusivity [View article]
    Yes, very. I would refer anyone interested in more details of Judge Moss' comments to read the Law360 article, which has also been posted to various stock chat boards in the last few days. Google is your friiend, at least for this type of research.
    Mar 18, 2015. 10:57 PM | 2 Likes Like |Link to Comment
  • Amarin Argues In Court For Vascepa Exclusivity [View article]
    The other unprecedented action was the rescission of the SPA for the ANCHOR clinical trial, as described in the last link in the article. Two other notorious actions by the FDA, if not truly unprecedented, were the long delays in process for ANCHOR-related matters and the unscientific approach taken in the briefing papers for the ANCHOR advisory committee meeting.
    Mar 18, 2015. 10:52 PM | 4 Likes Like |Link to Comment
COMMENTS STATS
215 Comments
302 Likes