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  • Hold off on bargain shopping - El-Erian [View news story]
    Very well articulated!
    Oct 12, 2014. 04:06 PM | 2 Likes Like |Link to Comment
  • Retirement Strategy: It Is A Correction, Not A Crash [View article]

    "Makes you kind of wonder where stock prices would end up without the Fed, doesn't it?" The Fed has been tapering its bond purchases since January and the stock market kept rising until now. Yes, October will see the end of bond purchases and the stock market is in correction mode. However, I do not see a direct cause and effect with the exception of traders using this as an excuse to sell short and capitalize on the anxiety caused by the end of QE, Ebola and ISIS. Traders love volatility and look for any opportunity to stoke selling in order to create a more volatile environment that they can take advantage of.
    Oct 11, 2014. 06:45 PM | 5 Likes Like |Link to Comment
  • Alcobra ADHD Drug Disappoints [View article]
    Z, the fact is that this data was released during a correction phase of the stock market where small cap and speculative companies are seeing their stocks get crushed in the absence of company specific news. So when a company releases news of any kind in this type of market that news is scrutinized for any reason to sell because at the end of the day traders do not want to be long anything when the technical indicators are breaking down. So for many traders who are almost exclusively focused upon stock prices to tell them how to trade, those people were disappointed by the ADHD MDX press release and conference call. For those, like me, whose focus is less on the stock price and more on the prospect for the company and its products or services, my response to the Phase III release was far different. The way I see MDX is that it addresses a multi-billion dollar global market for ADHD diagnosed patients who right now only have drug treatment choices which subject them to various side-affects Since MDX has not demonstrated any side-affects, if approved MDX should capture a sizable share of that market. Even if MDX does not have as high of an efficacy as the top selling drugs on the market, some may choose MDX because of its lack of side-affects and others might choose to combine MDX with one of those other drugs in hopes of getting incrementally better response without increased adverse affects.
    Oct 11, 2014. 11:00 AM | 1 Like Like |Link to Comment
  • Alcobra ADHD Drug Disappoints [View article]
    If I understood management in the conference call and subsequent Q&A, when excluding the four extreme placebo responses MDX showed a statistical positive response in both the inattentive and hyper-active sub-groups. They have yet to release the secondary endpoint data analysis, but I am pretty certain that this is what management indicated.
    Oct 9, 2014. 11:48 PM | Likes Like |Link to Comment
  • Alcobra ADHD Drug Disappoints [View article]
    Z, from my comments you can probably tell that I believe that the company was fully justified in removing the four placebo group subjects. Assuming that this is an accurate assessment, the removal of four subjects does not jeopardize the study as 144 is still roughly 50% of the total subject population.
    Oct 8, 2014. 11:30 PM | Likes Like |Link to Comment
  • Alcobra ADHD Drug Disappoints [View article]
    Matt, the adjusted placebo response score was given in the original press release. That statement was as follows,"In the mITT analysis, there was a mean change on the CAARS-INV from baseline to the final visit of 11.6 in the MDX treated group as compared with a mean change of 8.7 in the placebo treated group (p<0.03)."

    In the paper that I provided a link to above in one of my responses to you indicated the typical range of placebo responses for historical ADHD study populations. You are correct that -9.6 falls within that range, but that does not change the validity of excluding the four extreme responses.
    Oct 8, 2014. 07:16 PM | Likes Like |Link to Comment
  • Alcobra ADHD Drug Disappoints [View article]
    David, management did indicate that as evidenced by the impact that these four greater than three standard deviation subjects had on the entire placebo cohort scores that these scores were extreme outliers. I also have absolutely no problem with the very supportable decision to exclude these outliers. Conversely no one has pointed out that statistically reducing the placebo cohort from 148 to 144 does not adversely change the statistical strength of the study.
    Oct 8, 2014. 06:51 PM | Likes Like |Link to Comment
  • Alcobra ADHD Drug Disappoints [View article]
    Robert, on the conference call during the Q&A session management indicated that there is historical precedent and that they would endeavor to get that information to the analyst who asked the question. That being said, an important consideration with how much "slack" that the FDA Advisory Committee may give MDX has a lot to do with the very good safety profile for the drug. In my opinion when a drug has a questionable safety profile the bar for approval recommendation will be much higher than for a drug with a very good safety profile.
    Oct 8, 2014. 03:52 PM | 1 Like Like |Link to Comment
  • Alcobra ADHD Drug Disappoints [View article]
    Matt, from what was disclosed on Monday and the explanation why these four subjects were excluded, I see very little to justify the stock price action. To that end, there was certainly no reason to categorize the study as a failure as a certain journalist did. Company management stated in the conference call that the placebo responses were "extreme" and beyond three standard deviations. From reading about how the CAARS assessment is implemented, there is a certain level of subjectivity involved as the test administrators are not standardized from one study location to another. Here is a quote from a paper that I am attaching a link to: " Placebo responses in clinical trials of adults with ADHD vary widely, with reported improvements (reductions) in Conners’ Adult ADHD Rating Scale-observer rated, short version (CAARS:O-SV),18 ranging from 6.0 to 10.4 points". Here is the link:

    This is all very interesting reading and certainly introduces the difficulty of using human administered assessment tests to evaluate changes in behavior. Interestingly, the attached paper does indicate that as far as behavioral conditions go, ADHD tends to show a lower placebo effect compared to depression, etc.
    Oct 8, 2014. 01:14 PM | Likes Like |Link to Comment
  • Alcobra ADHD Drug Disappoints [View article]
    Robert, the fact is that the study design allowed for the exclusion of outcomes that exceeded three standard deviations across all subjects, not just the placebo group. We can only speculate why there for four exclusions in the placebo cohort and that three of the four were from the same treatment center. There are several explanations for how this could happen, but none of them to my knowledge have to do with study design problems or intent to manipulate the results. However, as far as statistical studies go, I have not heard anyone argue that the practice of excluding three standard deviation outcome is unusual.
    Oct 8, 2014. 12:12 PM | Likes Like |Link to Comment
  • Alcobra ADHD Drug Disappoints [View article]
    Robert, what do you mean when you say "applied non-uniformly"?
    Oct 8, 2014. 11:41 AM | Likes Like |Link to Comment
  • Alcobra ADHD Drug Disappoints [View article]
    David, I concur with your assessment as does every major biotech analyst which covers ADHD. The only people who seem to have major problems with the handling of the placebo outliers seem to be columnists such as Adam Feuerstein who was very quick to label the Phase III results a "failure". This pronouncement in the form of an editorial was made public just minutes after the company issued its press release. It seems to me that only the FDA can label a Phase III study a failure. But Mr. Feuerstein, who is not a scientist and not a statistician, published an editorial prior to even hearing management's discussion of the study and that editorial alone seemed to turn investor sentiment that was initially positive after the press release decidedly negative. In spite of almost unanimous support for the study results from professional biotech analyst, Mr. Feuerstein's editorial seems to continue to weigh on the stock.
    Oct 8, 2014. 10:54 AM | 4 Likes Like |Link to Comment
  • Alcobra ADHD Drug Disappoints [View article]
    Matt, I have been following ADHD and listened to the conference call Monday morning. Based upon the unblemished safety profile for Metadoxine, the consistent performance of the drug in Phase II trials and the fact that the 3 standard deviation rule for this Phase III study was part of the design of the study and applied to both the placebo and control side of the double blind study participants, I truly see very little reason to question the validity of the top line results. The stock dropped from $20 per share to around $13 per share on higher than average volume before the results were released indicating significant short selling. This significant price move shook the confidence of ADHD traders going into the study and the introduction of anything other than a straightforward positive study result was all that it took to shake the weak handed traders out of the stock.
    Oct 8, 2014. 10:02 AM | 4 Likes Like |Link to Comment
  • 4 Reasons The Jobs Report Stinks [View article]

    The factor effecting that group is a longer time spent in school.

    Oct 4, 2014. 11:17 AM | Likes Like |Link to Comment
  • 4 Reasons The Jobs Report Stinks [View article]
    888, you are dead on. Labor Force Participation rates peaked in the mid-1990's when the oldest baby boomer was 50 and today the youngest baby boomer is 50. The participation rate was driven up from the mid-1970's until the mid-1990's by the confluence of the bulge of the baby boomer generation coming of age and women entering the workforce in unprecedented numbers. After the mid-1990's the percentage of women in workforce stabilized and by the mid-2000's the oldest baby boomers were beginning to retire. Another trend that is pulling the participation rate down among young adults is the increasing number of young adults who go to four year colleges and furthermore the increasing number who then choose to go to graduate school.
    Oct 3, 2014. 08:57 PM | 2 Likes Like |Link to Comment