There's designing the trial, running it, analysing the results...

There's designing the trial, running it, analysing the results and then FDA approval. I am guessing 18 months. No wonder MSB's wanting to do this post approval. May put this indication on the back burner if they can't get their approval up front.
ARDS is where it's at now. Is a Tier 1 indication, they are running a randomised control trial on a good number of participants. Can always come back and do an Adult aGVHD trial after Covid ARDS gets approved. In the mean time can use it for aGVHD off-label.
When MSB presents data to the FDA for Covid ARDS they will make a strong case, and with the political dimension from Covid there will be no room for the FDA to squirm. All that's uncertain is the level of effectiveness. The Pilot 12 patient trial was compromised by multiple different treatments that were tried before Rem-L. I am not expecting an equally slam dunk result, nor do we need it. The issues will get narrower and the brilliant minds keener, the closer we get.