I have received the following letter from the company in regards to its week of March 18th data release on its schizophrenia drug in Phase II/III.
"Dear Scott,
Thank you for approaching us with your clarification questions.
The independent Data Monitoring Committee (DMC) will make a recommendation to the Company regarding the number of patients that are needed to complete the study by meeting the cognition endpoints (including the primary and certain secondary endpoints). Although specific data will not be released, the strength of the cognition signal will be crystal clear to the Company and its investors.
For example, if we report that only, say, 100 patients are needed to complete the study (meaning a total of ~335 patients in the study, since the interim analysis will be done on ~235 patients), then this means that the cognition signal is much stronger than anticipated, since we originally powered the study with an assumption that we would need 450 patients to achieve statistical significance. On the other hand, if we need another 1,000 patients, it will be clear that the signal is very weak. We view this data as an extremely significant milestone for the future of this study and for the Company as a whole, even though more detailed data will not be known at this point. We also believe that a positive interim release will significantly accelerate partnering discussions regarding the program.
Following the PR with the DMC’s recommendation regarding the number of patients (which will be released during the week of March 18), the Company will issue an additional PR disclosing its plans regarding the study and the program as a whole.
The mechanism of the DMC was established in order to maintain 100% blinding of the study, which enables us to receive the above data, without paying any statistical “penalty” generally required when un-blinding data, and without introducing any bias to the future conduct of the study.
I hope this answers your questions, since the last thing we want to do is to mislead our investors.
All the best,
Tsipi"
The above is self explanatory. If less patients are recommended by the DMC, the company will know the data is POSITIVE without being unblinded to it, avoiding possible bias and additional costs to the company, which in my view is a sign of good management. Therefore, this is a strong catalyst event upcoming as less patients = GOOD RESULTS, MORE = POOR RESULTS, IN BETWEEN = AVERAGE.
A blind man does manage to get around my friends 🙂 Doing good DD is digging deep and contacting companies, not assumptions.
The additional catalysts the company has coming this year also provide strong value drivers here, notwithstanding its good cash position and burn rate.
GL!
Scott
