First of all, I hope you understand what approval rate looks like in the entire biotech/pharma space and the years of trials needed plus the $$ required to get approval even before a treatment can go to market.
Secondly, do you know any company that received FDA approval with most of their trial subjects dead during P1 or P2? How will any company prove their treatment works if subjects do not live long enough to finish the study? Let's say for a minute that HemaXellerate showed positive response after 6 months in most of its subjects then in subsequent months, those subjects all passed. BMSN will meet its primary endpoint at 6 months of P1 but what would the secondary endpoint look like? Are they going to keep repeating P1 or do P1a, P1b and so on? How will BMSN ever prove their treatment works? Is it important that a treatment shows positive response or should it promote overall survival or good median survival? If treatment response is positive, why are patients dying and how do we eliminate positive response or death as an event that is or is not occurring randomly (chance) if we have a small study size like 10?
The issue here is that the company has not disclosed the Power of the study, and one can only assume that this is going to be a randomized, double-blinded study given the study size which would justify such a small study size. I already commented that a study can have a small size as long as the Power is high enough. But given the aggressive nature of the disease, it really makes more sense to increase the study group to at least 30 and ensure the study can yield data sufficient to derive statistically significant data from a bigger group in the event study subjects dropped off for one reason or another.
I highly suggest you check with people in the medical/science field and get another opinion on this view. They will confirm and support my view without calling me names.
Why is it such a big secret to not release even raw data of this study so that one can at least look at it for further review? When they don't tell you, it's because they don't want you to know. Please save the "because it is competitive information" argument.
So, why hasn't the FDA given the green light to even start a trial? You realize more than 85% of IND applications are approved upon submission and review? How long is BMSN going to drag this? Of course the argument there will be "It's not BMSN, it's the FDA." Right?
This is what I meant by the "numbers" being stacked against BMSN for HemaXellerate.
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