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Re: voova99 post# 18321

Tuesday, 11/13/2018 8:07:25 AM

Tuesday, November 13, 2018 8:07:25 AM

Post# of 44784
Thanks for posting this Voova99. It's very helpful to demonstrate how psti/allo/fdapproofed work in harmony to twist and shape shift to kick the can down the road when the primary study is unremarkable.

The primary and secondary endpoints here are meaningless. Sorry. But they know it's true. FDA and CMS are not going to approve and pay for MWD... That's why this program has been delayed. They missed the most important 'primary' endpoint, didn't study it, amputations.

So what do they do? Tout other 'observations' and data points. NONE of which were powered for safety or efficacy claims.!!!!!

How do e know this?!?! Look at what they are focused on... NOT MWD... That's for sure.... Don't be duped. We are YEARS away from ANY approvals/contracts, R18 INCLUDED.