Ready Steady Go, page-55

Combination trial, the product remestemcel-L has been through the hoops over a decade, currently up for BLA with the FDA, last step prior to release. Most safety issues have been addressed, or that is not seen, which is part of what a P2 trial is about, as is dose ranging, which is what the 12 people who were in the compassionate use group were probably doing too. Manufacturing aspects are also addressed in the BLA, though not any ramp up that might be needed for COVID-19/ARDS.

Basically a very significant amount of ground has already been covered, main thing is to work out the efficacy in this indication, ARDS. Unlikely to be a follow up P3 trial beyond the Phase 2/3 unless somehow the Cardio Thoracic Surgeons Network, ICAHN or INChoir some how messed up. Not likely.