When it comes to the use of PLX-PAD we're caught in a Catch 22 situation here in the U.S., and perhaps elsewhere, because it's not yet approved for anything anywhere. Trump can advocate for drugs that exist as approved for other diseases, but to make PLX-PAD available here, based on trial evidence, he'll need to dictate to the FDA to abandon all their rules and regulations and simply approve it. Lacking that, perhaps it could be called a massive trial where virtually any Dr. could prescribe it's use, and report the results to an FDA database, essentially as you'd do in a Phase 4.
My point is, I believe the Govt. would find a way to do it, but it would greatly stretch all their rules and regulations. The easiest way of making it happen would be a bulk purchase by the Federal Govt. They could then provide it to everywhere it is needed. The price they pay per dose may not be as great as PSTI will be paid in the future, but it will be high enough to put PSTI on the map. While coronavirus may disappear in a year or two, pneumonia will not, and if our drug is successful, it will become the SOC for the treatment of pneumonia for the foreseeable future.
It's my understanding that some European countries are looking to approve PLX-PAD on submission of more data on CLI. They too might expedite the decision greatly to make it available for coronavirus, but the company will need to provide that interim data. Hopefully this can happen in a matter of weeks, as that's what's needed for more evidence on it's benefit in pneumonia. Once data's revealed for a hundred or so who've received the drug, hopefully the evidence will be so great that countries will do whatever is necessary to make it available to all who need it.
Gary
