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Re: Auto1 post# 15498

Friday, 09/14/2018 9:57:14 AM

Friday, September 14, 2018 9:57:14 AM

Post# of 44784

Actually, these endpoints are weak from a reimbursement standpoint.

Actually, the only "endpoint" that is significant for approval is the one defined as success by the FDA/EMA/etc. Reimbursement is a policy issue and it comes much later.

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.



1) BINGO, we got it, reductions in amputations

2) FDA does not examine changes in patient's life style or change in work habits. Many of the relevant patients are elderly and retired. We're looking for relief, from pain, amputation, death, massive cost of care. That's precisely what PLX-PAD does.

3) BINGO, we got that too.

Looks like Pluristem is off and running! We're getting closer to the target by the day!