Pluristem Therapeutics Inc (PSTI)

[skitahoe]

Jamie,

I can't remember where I heard or saw it, but I believe someone indicated that they've had over 40 events in the trial. I hope everyone knows that event is the polite way the FDA refers to death. If it's correct that over 40 have already died in the trial, I'd have to suspect that it's nearly fully enrolled.

The trial will enroll 140 ventilator patients. I believe statistics are improving some for ventilator patients, initially I believe over 80% on ventilators passed away, for talking purposes, lets say it's improved to 60% passing away. That would be 102 passing away under current treatment if my 60% figure is near correct. To put it another way, if we had two groups of 70 each, one on PLX-PAD the other on placebo, 51 of each group would be expected to pass if PLX-PAD had zero efficacy.

I don't know if the people monitoring the trial are permitted to unblind the trial at any time prior to it's full evaluation, but it would seem prudent for the monitors to be able to take a peek after perhaps 50 deaths, roughly half the total if PLX-PAD had no effect. What if they did look after 50 deaths, and what if they saw that over 40 of those who passed on were on the placebo. Do you think they'd tell their superiors about it. Might the trial be ended early?

If I heard correctly and over 40 have evented, I would suspect at this point we're only a matter of perhaps 6 to 8 weeks at most from completing the trial. The primary completion date is September 2020, so that should be about right.

Here's a link to the trial:

https://clinicaltrials.gov/ct2/show/NCT04389450?term=PLX-PAD&draw=2&rank=1

It would be nice if the company updated the trial, I'm certain all listed sites are enrolling by now, more sites have been added, but an update is needed to say so.

If I remember correctly the company indicated 4th quarter for reporting the trial. A completion in September could have data out in October, the first month of the 4th quarter. If the data's as strong as we hope, I believe it could achieve approval rather than requiring a larger Phase 3.

Gary