Pluristem Therapeutics Inc (PSTI)

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Actually, these endpoints are weak from a reimbursement standpoint. Unfortunately insurance companies could care less about improvement ins number of steps. 83% improvement means what? What real benefit to the system? I get it, its very meaningful for the patient that can walk further, but are they back to work? Off gov't assistance? Disability? Likely not. Furthermore, the delay to amputations and revascularization are likely not statistically significant enough, although statistically significant.

The type of results that it will take to get from fast track to expedited review need to look like 1) Reductions in amputations - patients requiring no longer requiring 2) Patients coming off of disability and returning to work 3) Revascularization via angiogenesis, verifiable through imaging, etc. Without these, commanding a price point for 'stem cell' type activity will be virtually impossible. P-values in the .005 range IMHO