I know that's coming at some point. I believe that some investors believe that the data will be sufficient to gain approval from some regulators, but not the FDA. Of course until they have the data no one knows, but I believe the benefit is significant. The thing about covid-19 is you don't need to wait years to know, a month or so into the trial, if the results are close to what happened with the first 7 to try the drug, even if the trial has longer to go, the clinicians could recommend terminating early with such positive results.
I know they're testing at various dosing levels, it's hard to say if the lowest level could be as effective as higher levels, but if it is, it would bring the price down as less would be required per patient. In many ways I believe that PLX-PAD may be like stem cells. As a stem cell recipient I know that not that many cells were needed, they reproduced when they arrived at the right place. I don't know that's the case, but if it is, a fairly tiny dose may be all that's necessary, though more cells will probably be faster acting.
I'm completely unsure, but wonder if people treated with PLX-PAD have benefits never considered in the trial. I.E. were improvements noted in organs other than the injected tissue when it's used on CLI. If the injected cells do reproduce and migrate in time, could benefits be seen in the heart, or other organs. It would be interesting to see if that's been studied with people who entered other trials years ago, we might find unexpected benefits.
Gary
