Your claim that Pluristem has injected well over 200 humans with 1 known adverse event is once again incorrect and I will show you below. May be close to 200 as it is an estimate, but your "well over" claim is baseless.
First of all, I am going to eliminate the current CLI and HCT trials because we don't know how many have been enrolled, and we certainly don't know if there's been no adverse events.
PAH phase 1 trial... 9
Hip phase 1/2 trial...20
CLI U.S. phase 1/2... 12
CLI Germany phase 1/2...15
Compassionate Use...3
IC phase 1/2....135
For a grand total of 194.
So before you go off on a tangent, the I/C trial is an estimate of sorts. Originally, the trial was supposed to be for 150 patients. Of those, 20 left the trial early, hence the call to enroll 20 more. And I would think it's safe to assume 2 of those additional 20 also left early, requiring 2 more to get full enrolment.
So we will keep that trial at 150. But now you must remember that there were 4 arms to that trial, one being placebo. I have given a the placebo arm a conservative number of 15. That would allow for 45 PLX dosed and 5 placebo for each group. I realize placebo is not in each group, but it puts it in relative terms to show that it would be a reasonable number, and possibly on the low side. I also threw in 3 compassionate use, which most likely shouldn't be there.
So for you to say well over 200 is shown to be incorrect. It is close, and it is a lot of people. But not what you claim.
Another mistake you make yet again, is insinuating that just because they originate from the same cell, the same safety results are assured. You have claimed this many times in the past.
I don't think any lab technician, investigator, or FDA/PMDA/any agency in this world would agree with that. Tweaking it in any way, changes the cell in some way. That's why the safety issue was a yes I'm the HCT trial.
We have zero known patients treated with R18, and likewise have zero human safety data. Do I think it will be the same as PAD. Yes. But until we see something factual, it's just a guess. Try doing some real DD for once. LMAOx1000
