Pluristem Therapeutics Inc (PSTI)

[Straightshot]

Interpretation of the primary efficacy endpoint in the CLI trial... according to information on pg #17 of the 2018 Pluristem Company Presentation the end point reads: "Time to occurrence of major amputation of the index leg or death (AFS)"... this is a double blind placebo controlled trial... with, IMHO, an arbitrary end point not compared to any SOC will the results be based solely on the time difference between the PSTI cell therapy and the placebo when applied to amputation or death... in other words... someone gets the placebo and needs their leg amputated in 4 months and another patient gets the cell therapy and doesn't need a leg amputated... that's an easy one to see but what about a patient with a much more severe CLI and gets the cell therapy but requires a leg amputation while another patient receives a placebo and doesn't need an amputation... they project 246 in the trial... I wonder if it is strictly a numbers game... better results (greater than 50%) with the cell therapy and you get approval???... or less than 50% but lots of improvement shown in the secondary endpoint criteria... I hope the numbers will be skewed way higher on our end so it will be a no-brainer for the FDA and the EMA... now let's get to work and get this freakin' thing finished!!!