The ultimate issue has been the cell line - the JadiCells.
As I see it, we first lost ~ 1 year, as there was the haggling over whether TSOI actually bought the rights to the cells or not.
Then we have lost another year, with the FDA requiring that the cells age a year.
It is what it is. I don't think it is anything wrong that TSOI did, but this is how business goes sometimes. I do still have hope that the aging of the cells is the last obstacle to beginning the ARDS trial.
In my head I give the trial a 50% chance to start - as $ still needs to be raised for the P3 trial. BUT, of all types of drugs, this is a relatively short horizon for a P3 study. For this indication, you know right away (within weeks) whether the "drug" did it's thing and was successful.