As stated earlier... These recent data on the endpoints described are WEAK. Please re-read the article and quotes from the principal investigator, and look at the p-values. While 'significant' they are NOT significant enough to be considered 'blockbuster', by a looong shot.
The best evidence that what I'm trying to educate you on are the following:
1) The analysts and investors response was a yawn. Look it up.
2) The PI highlighted 'walking distance / delay to amputations' - Do you really think these are the endpoints that PSTI hopes to crush?!?! Looks to me like grasping for straws.
3) 'Changes' to the PIII study, not an expedited conclusion. Looks like PSTI is getting a 101 on trial design.
Inexperience is far more expensive to hire than Highly experienced...
zzaatt
Friday, 09/14/18 09:57:14 AM
Re: Auto1 post# 15498
0
Post # of 15508
Quote:
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.
Quote:
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!
