Pluristem Therapeutics Inc (PSTI)

[Spideyboy]

For the Hip-Fracture PLX-PAD trial that is due to meet its Estimated Primary Completion Date in July 2020, then the study can't meet it's noted time.

If it is to meet the July 2020 mark, then given the 26 week (half a year) clinical trial time-frame to get to the 'Primary Completion Date' mark, the they need to complete enrollment by end-2019. While I appreciate that it initially takes considerable time to bring on-board the 19 Clinical Trial sites, it is clear the study will not be fully enrolled in the next few weeks.

Given the slower uptake at the beginning of a study, and reaching an average of 8 patients per months, then going forward with all sites still active, then perhaps we can hope for an accelerated enrollment. If they recruit at 1 new patient per month per site, total 19 per month, we are looking at another 6-7 months for full recruitment, then we need to wait 26 weeks from last patient enrolled. So we would be looking definitely for end 2020 earliest, and probably early 2021 for data read out. If they manage 2 per site, then recruitment would complete in March, and then 6 months later, September, data in earliest August 2020.

For PLX-PAD in CLI however we have a guaranteed potential EU approval data date for April-June 2020. That is the key thing investors should be looking at regarding PSTI at the moment.

I would now see Hip-Fracture for end 2020, early 2021 for data though.

Now that we know we should hear BARDA feedback soon, then if they provide the funding then we might expect R18 anti-ARS for 2H2020?

In either case, with the EU CLI data, 2020 is the first year we should hopefully see meaningful shareholder value creation.