Seeking Alpha
View as an RSS Feed

Fundamental Investor  

View Fundamental Investor's Comments BY TICKER:

Latest  |  Highest rated
  • Orexigen: What Happened And What's Next [View article]
    I agree the study is not designed to show CV benefits but patients and physicians will notice it. I don't understand how people can ignore the potentials there. An a long-term investor, the question is really whether this potential is priced into the stock.
    Mar 13, 2015. 12:33 PM | Likes Like |Link to Comment
  • Orexigen: What Happened And What's Next [View article]
    Thanks for the clarification and explanation. In addition, Bupropion was not known to have any adverse CV effect, which is what people are most concerned with a weight-loss pill.
    Mar 12, 2015. 09:54 PM | Likes Like |Link to Comment
  • Orexigen: What Happened And What's Next [View article]
    Here it is:
    http://1.usa.gov/1BJsC4C
    Mar 12, 2015. 02:13 PM | 1 Like Like |Link to Comment
  • Orexigen: What Happened And What's Next [View article]
    BTW, more placebo-treated subjects were discontinued due to blood pressure (5.2% vs. 3.5%).
    Mar 12, 2015. 12:08 AM | Likes Like |Link to Comment
  • Orexigen: What Happened And What's Next [View article]
    Well, you seem to be questioning the trial design, that is the validity of treatment discontinuation at the Week 16. I have no expertise to know the reason for this design; it's puzzling to me too, but it's approved by FDA.

    However, this has little impact on the data. The document that I read states "the Week 16 BP criterion contributed to the decision to discontinue treatment in 3.5% of Contrave-treated subjects and 5.2% of placebo-treated subjects" (p.5 of Summary Review for Regulatory Action). Out of those 3.5% discontinued, how many would possibly have had MACE events but did not have? BTW, as I have said, they are included in the ITT analysis.
    Mar 11, 2015. 11:52 PM | Likes Like |Link to Comment
  • Orexigen: What Happened And What's Next [View article]
    It was found in the efficacy study that there is a slight increase in blood pressure and heart rate in the Contrave arm. FDA is rightly concerned and hence the label. The point is one could hardly get any better assurance of safety in a new drug than what Contrave offers - existing safe compounds and solid data.
    Mar 11, 2015. 08:51 PM | 1 Like Like |Link to Comment
  • Orexigen: What Happened And What's Next [View article]
    The interim data published by Orexigen is based on an intent-to-treat analysis, which means data is collected for all patients at randomization regardless of whether they discontinue the treatment or not. FDA stated that they also conducted an on-treatment analysis, which led to the same conclusion.

    With respect to the beginning data (first 16 weeks), both arms starts at 0 and the initial increases are more subject to the influences of random noise. You should really look at the Kaplan Meier analysis (the figure in OREX's filing) that shows the widening gap (also explained by an earlier SA post) and hence less likely due to random noise at any given time.
    Mar 11, 2015. 08:44 PM | 5 Likes Like |Link to Comment
  • Orexigen's Cardiovascular Safety Data Is A Breakthrough [View article]
    Thanks for a great article and very impressive number crunching! I had also been skeptical about all anti-obesity drugs, but this data point is a game changer for me and I initiated a position.

    I think FDA's post-marketing approval process is flawed. Once the drug is approved, implying positive initial data, and is available to patients, there is a good possibility that a patient would drop out of trial once he realized he is not losing his/her weight, regardless the disclosure of the interim data. So one way or the other, the Light trial is likely to fail. So I also agree that the second trial would likely never reach the enrollment or would fail due to large drop-outs. The problem is it's too easy for patients to tell if the "drug" is working or not. I wonder what would happen from FDA's perspective. I think they would have to rethink and modify the protocol. Any thoughts?
    Mar 4, 2015. 11:55 PM | 3 Likes Like |Link to Comment
  • Has The 'Surge' Gone Out Of Intuitive Surgical? [View article]
    Anyone with some brains would also ask these "doctors" if they continue performing da Vinci surgery. I hope your doctors all quit as otherwise there would be too many brainless patients who would agree to a da Vinci surgery by surgeons who "speaks horribly of" it. BTW, even the most vocal critic of da Vinci compares it to other MIS but not the traditional surgery.
    Sep 21, 2013. 05:29 PM | Likes Like |Link to Comment
  • Has The 'Surge' Gone Out Of Intuitive Surgical? [View article]
    My point is there is no gold standard for equipments/procedures. FDA doesn't demand a randomized trial and they must have good reasons for that.
    Sep 17, 2013. 09:58 PM | Likes Like |Link to Comment
  • Has The 'Surge' Gone Out Of Intuitive Surgical? [View article]
    Let's suppose there is a competitor system available today that is similar to da Vinci but has no clear functional advantage. If you are a patient, would you choose the new machine over da Vinci? If you are surgeon, would you rather be trained for the new system or da Vinci? The newcomer can compete in price, but the price is not the top concern in the health care business.
    Sep 16, 2013. 10:34 PM | Likes Like |Link to Comment
  • Has The 'Surge' Gone Out Of Intuitive Surgical? [View article]
    Your criticism about company's unwillingness to conduct randomized trials appears pretty ignorant to me. How many medical equipments that you know have gone through randomized trials? Has any other MIS (e.g. laparoscopic surgical equipments/technique) gone through randomized trails? What kind of randomized trials for surgical procedures would be acceptable to you and then the medical community?

    It's puzzling to me why a panic bottom would likely not hold. A previous low is always a support (meaning the price action is more likely up, right?). If it's reached by panic selling, it means it's an extremely oversold price level, and if "panic" means anything, it's a support that will more likely hold. I do agree that the July low will likely be tested again. But that of course depends on how the company's business evolve in the next few months.
    Sep 16, 2013. 10:16 PM | 1 Like Like |Link to Comment
  • Will Intuitive Surgical's Quarterly Miss Be Minimally Invasive To Its Long-Term Growth? [View article]
    I always feel this is a very conservatively run company. They tossed out a very conservative guidance, as they usually do, and the stock got punished badly. But it's unlikely they'll disappoint again from here on. I feel the stock has made the bottom. The large buyback can only help here.
    Aug 7, 2013. 03:12 PM | Likes Like |Link to Comment
  • Exact Sciences - The Rotten Sniff Test (1 Of 5) [View article]
    I found your article enlightening but it seems to me that both you and EXAS have made an inadequate assumption:

    A GIVEN SENSITIVITY MEANS THE PROBABILITY THAT A GIVEN INDIVIDUAL WILL BE SUCCESSFULLY TESTED


    I believe the numbers that you and EXAS presented using successive testings are based on this assumption. However, unless a trail includes a repeated test on the population that is tested negative and still results in similar sensitivity, this assumption is not valid because

    A GIVEN SENSITIVITY SHOULD MEAN THE PERCENTAGE OF THE POPULATION THAT CAN RESPOND (OR IS SENSITIVE) TO A TESTING METHOD

    So a given individual may not be sensitive to a given test no matter how many times it is repeated. In that case, the two tests may be complementary as they may have different sets of targeted population?
    Jul 24, 2013. 10:41 PM | 1 Like Like |Link to Comment
  • Will Intuitive Surgical's Quarterly Miss Be Minimally Invasive To Its Long-Term Growth? [View article]
    Health care today is not nearly what it used to be when many governments introduced universal health care decades ago. Today's medical science is capable of doing so many things such as replacing most of human body parts that are really human body engineering. Obviously, no government can afford all the advanced medical technology for all of its citizen. So, a two-tier system where the government runs a basic health care while private insurers cover whatever more people want is the only way to go, in my opinion. So, in a government run health care, patients or private health care will pick up what's not paid by the government. A case in point: many Canadians come to US to get medical services.

    As I argued in my earlier article, I see da Vinci used in almost all surgery, including neurosurgery where de Vinci's precision control will surely be an advantage. For that to happen, it just needs ISRG or someone else to develop specialized tools.
    Jul 21, 2013. 10:15 PM | Likes Like |Link to Comment
COMMENTS STATS
24 Comments
15 Likes