Ann: Mesoblast Update on COVID-19 ARDS Trial, page-925

Ok after some digging I've found the answers since you lot are no help
Current FDA priority review team will not give RYONCIL fast track approval with regards to aGVHD.
FDA has requested at least one more controlled study be completed for further evidence of effectiveness.
MSB dug their heels in, requested a "Type A meeting" with the FDA to plead their case, which we are still awaiting the minutes of (due 30 days after meeting held Nov 17)
If FDA don't change their mind which MSB seem to believe they will not, MSB will begin a dispute pathway.

I'm attempting to post this for clarity as the waters seem to be very murky with RYONCIL with its implementation for two seperate illnesses aGVHD and ARDS.

The BLA to treat ARDS is not the same as the BLA to treat aGVHD. RYONCIL has been shown to be effective in the treatment of aGVHD. It seems quite unreasonable to wipe it off so early without completing the process with the FDA.