Pluristem Therapeutics Inc (PSTI)

[Melon4head]

PSTI will not get the go ahead until a safety study in healthy volunteers is completed. All medications require this piece for all indications for this or any "drug". So, even though there have been a few human studies with safety- I believe that they have not been done for ARS at a specific dose.

The article today even states this:
"With this pathway, the FDA uses animal efficacy studies and human safety data as the basis for product approval."

As we all know, there is only one safety study being conducted. Here is the study called: "A Study to Evaluate the Safety of Intramuscular Injections of PLX-R18 in Subjects With Incomplete Hematopoietic Recovery Following Hematopoietic Cell Transplantation"- Website:
https://clinicaltrials.gov/ct2/show/NCT03002519

The study will not be completed until 2019.


Everyone is talking about efficacy, and all of the papers confirm this focus and the great outcomes.. That data is sound. What is in question is how will humans respond to the pharmacodynamics of PLX-R18.

I hate to throw water on the flames, but this is a real fact that governments will require. Yes we will get bumps up along the way, but, in my humble opinion, we may be faced with a longer period of time until the safety data is satisfied.

Please don't all of you gang up on me at one time!!!