Replies to post #33626 on Pluristem Therapeutics Inc (PSTI)

[jaime9_2000]

Hello xov,

Those that listened to PSTI's April 22 presentation said that PSTI will release CLI Phase 3 results in July/August. That could be huge. If we get good results, we can apply for marketing approval in Europe. It would be awesome if we could market our product by the end of the year. Maybe the product will be used off-label for Covid-19 before our competitors get their foot in the door.

[zzaatt]

I think we have two distinct paths here:

1. the one whose dates you speculate about. I hope it will be much faster than that, given the emergency we have and the dismaying death toll.

2. The compassionate use of PLX-PAD in the US, Israel and Germany. I think this is more important, because any strong positive result will be impossible to keep from hitting the news, and once it's out, patients, relatives and doctors will insist on expedited action.

In any case, the latter will result in big upward moves even before any official recognition.

[xov]

Possible timeframes for official announcements? These are mostly guesses. I welcome any input from those of you who are much more qualified than I to speculate on this.

Apr 30 - Sign the EIB funding agreement
Late May - Approval for multinational clinical trial
Late June - Start of trial
Sep/Oct - Results (preliminary?)

Even though compassionate use is continuing, I don't expect to hear any more details on this from the company.

This timeline seems to be in agreement with the call today.

Pluristem intends to commence Phase II studies of PLX cell therapy in the treatment of complications arising from COVID-19 as soon as it receives clearance from regulators in the U.S. and Europe. Anticipating responses in the next few weeks, Pluristem aims to complete enrollment and treatment in a few months, by utilizing its logistical and technological competitive advantages to support effective enrollment.