Pluristem Therapeutics Inc (PSTI)

[skitahoe]

It's very difficult to anticipate when, or how frequently the company will announce news about how the compassionate use is going. When a formal trial, or trials begin, silence about what's happening could be the case for the duration, which hopefully will be short term. I cannot imagine any difficulty enrolling hundreds, to thousands, in a matter of days.

Personally, I believe that all in a trial should get the drug, the control can easily be all the others in similar circumstances, but I doubt if the FDA and other regulators will treat it that way. I do believe there is a possibility that even a week or two into such a trial, if clinician see an obvious advantage to the use of the drug, the trial may be ended early with the agreement of the regulators assuring approval essentially immediately.

I would hope the company in the near future will say just how many have now been given the drug under compassionate use provisions. I believe that all these people can be openly discussed, it's considered anecdotal information about how the drug is working as they're not in a clinical trial. I suspect the number will increase rapidly, unless the company calls a halt to such treatment.

Gary