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.
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!