Veziris Ventures

Veziris Ventures
Contributor since: 2013
Company: Veziris Ventures LLC
Maybe you're right regarding Spiro's comments. The press releases aren't so specific. Survival data depends on deaths, so the longer it takes patients in the trial to die, the longer we must wait to get the results, which is a positive indication. Timing the regulatory approval process is a difficult task, but most data is announcement around conferences such as ASCO.
I have been watching the case now in appeal. The European legal system, contrary to that in the US, deems that the plaintiff must demonstrate cause of damages in order to pursue a lawsuit. Since Istodax was rejected by the EMA and has no sales in Europe it is not worth following and focus should remain on the US.
FYI. vd6rt, I was referring to the first comment, which happened to answer your question as well.
You struck out. You went from questioning the quality of the drug to now questioning the numbers. I will simply answer you once and for all that we use the same estimates for the market value of the AML/MDS drugs used by analysts across the street . Please do your homework before you waste your time and mine.
For serious, fundamental investors, please ask the authorities in the field, Dr. Kantarjian and Dr. Garcia-Manero, who both know the field better than anyone else as agreed by the industry, and both strongly support the data and the quality of the drug versus competition.
I have indeed. And the data certainly indicates better than just 'marginal efficacy': "Thirty-day mortality from all causes was 4%. and Sixty-day mortality from all causes was 13%" and this compared to 4-week death rate of 26% and an 8-week death rate of 36% with intensive chemotherapy. Most importantly, the median age of the 46 patients was 77 yrs. As I pointed out, age has a significant impact on a patient's survival, which would suggest based on the data that sapacitabine has also even greater efficacy in a younger, MDS patient population. I would strongly suggest rereading the sections "Understanding the FDA" and "Valuing the History of Oncology" to better understand the value of sapacitabine and the data mentioned above in proper context. You are correct, however, in one thing - no drug has yet to properly treat AML and nothing in the clinic today outside of sapacitabine shows any promise in doing so. Sapacitabine is the clear and only frontrunner.