Ann: FDAs OTAT Agrees to Primary Endpoint for Back Pain, page-398

Excellent question 5cata. I am assuming you mean after we get the BLA for Ryoncil for paediatric SR-aGVHD will the insurance company pay (reimburse) the off-label usage for Remestemcel-L for say other conditions such as adult SR-GVHD, all-cause ARDS, sepsis etc in the US.

The short answer is I don't know (more versed on the Australian Healthcare System versus the US Healthcare System). If I had to guess I would say they would usually not reimburse for off-label usage (i.e. most likely the majority of patients would foot the bill) but I could be wrong. Maybe there would be a better chance of reimbursement for COVID-ARDS because there is real world data out there (i.e. seen as less experimental etc), again only a guess. It would be great if someone with healthcare reimbursement knowledge in the US system could give us a much more definitive answer. Either way it is my opinion that there will be a growing level of off-label usage (reimbursed or not) once physicians see in practice how powerful Rem-L is (with or without DEXA) in combating the life threatening cytokine storm that is also associated with other emergency conditions such as sepsis and all-cause ARDS).