The report points out that the VALOR study did not meet statistical signifigance for efficacy at the first look, so the number of participants was increased. Bottom line is that although the results are likely to be favorable, the effect will be statistically very unimpressive. This is "the Achilles Heel" of the SNSS story. The drug will likley be approved, BUT the heme-onc community will be unenthusiastic about its use.
Incidentally, I own shares in biotech's which are heavily shorted and I follow the short arguments very carefully. On more then one occasion I was persuaded to a position, and managed to
preserve capital that would have been lost by continuing the long position.
Maurice, why do you take offense? I am simply posting info from the Credit Suisse report. I initially was long SNSS until I realized that the VALOR study at best can show show that vosaroxin has a modest efficacy. It will be a year until the results are finalized. Moreover, newer drugs under development presented at Am Society of Hematology 2012 including Volasertib and Quizartinib will provide stiff competition. Shorting is a valid investment process and I am simply making my case. You can be educated, or choose to disregard my case.
Viewing your past posts, mghmd, I would note that you actually are very knowledgable on these subjects - - certainly more knowledgable than I. However, you are clearly a partisan of the alternative drugs, for which you may have very good reason. I do think that you put a little negative spin on the C-S report by completely disregarding their positive view of the expanded enrollment in VALOR. Now, at my leisure, I will go back to your various posts and see if I can learn anything from them. My apologies for my earlier post, in which I assumed that you were a physician manque, like so many of us. If your positions in some of those rather speculative biopharms are as huge as you say - and I have no reason to disbelieve you - you obviously have the courage of your convictions. Although I'm not sure that I'd want a physician with that much of a risktaking streak.
idiot - the first look into the VALOR study was just to see where it was trending, not a readout to #$%$ whether it met the final endpoint. if at the final readout the primary endpoint is not met at a statistical significance level, i don't think the drug will even get approved. The trend is positive in the direction of meeting the endpoint, thus the recommendation to increase the number of patients.
you are just trying to drive the stock down. you either have a short position or are looking to buy in at a cheaper price.
Credit Suisse has their opinion regarding the significance of the DMSB review in which the sample size was increased, and I have mine. Time will tell who is correct.. They regard the DMSB review mandating additional patients as "derisking" the bet on SNSS. For a study with 500 patients to require more patients to me, as a hematologist, indicates that the statistical signifigance of the results is likely to be marginal. In the setting of therapy of relapsed AML, where several new and exciting agents such as quizartinib and volaserterib are under accelerated development, I think that the SNSS drug will be a marginal player. I clearly disagree with Credit Suisse about the upside potential.
you are clueless. I have the last Credit Suisse Note January 14th. They have a $7 price target on the stock. it is their initiation report. "Still underappreciated but that could change ahead of phase III data". "We believe shares could move significantly higher before this event."
The report is from a restricted site and it wont allow me to copy it, but it reads:
"The intervention occurred 9/12 and the DSMB recommended a 50% increase in the number of patients. The sample size was increased to 675 patients......."