I think we all need to remember that less than a month ago this was trading for under $4, that's when I bought the last of my shares. We know anecdotally that it produces benefits in Covid-19, it won't be that long before they're confirmed by clinical trials. While I'm uncertain, I believe it's very possible the German's have been utilizing it in what's essentially a small Phase 1/2 Trial, results from that could come at any time.
Now we know the company has submitted paperwork for what they're calling a Phase 2 Trial. In fact, other companies running similar trials are calling them Phase 2/3, and I believe our trial will have the same approval potential, and actually it will be more like a Phase 3 Trial mainly because of its ability to produce commercial quantities of the drug. I don't believe it's competitors already have approved production capability that's normally associated with a drug approval, but I'm not certain of that.
Frankly it doesn't matter, if drug works the FDA's going to be willing to accept a lot of short cuts to making the product that wouldn't be approved under normal circumstances, but to my knowledge, PSTI has the capacity right now, the others don't.
Give it a little time, I believe once we get into the trial it won't take much time to be fully enrolled, and while I have no idea who the lead clinician may be, I've got to believe by one month after the last patient enrolls, that clinician should push to unblind the trial and report results. Normal approval criteria will be ignored, the FDA and other regulators will act without normal submissions based on raw data, just in the same way they are for other products. It may be something less than full approval, which can come later, but it will make the drug available to all in need of it if sufficient production is available.
It's said that coronavirus will have a second wave around November, if so, it will be totally different if the death threat has been removed by the availability of PLX-PAD. Not only that, the flu season, which typically kills more than coronavirus will be much less threatening, as pneumonia, which is normally the killer, will be treated with PLX-PAD as well. I don't know that we'll get back to permitting crowds to assemble, but if we have the treatment that makes it much less deadly, the fear of doing things like going out to dinner or seeing your friends will be far more acceptable to all.
Gary
