RTB First they have no approved trials underway

RTB

First they have no approved trials underway yet, FDA gave approval to proceed with application.

They must first get stem cells from a donor, the cost would be high I would believe and to get mass qty's difficult ?

While under general anesthesia, the donor's bone marrow is harvested directly from the hip bones through a large needle. In a peripheral blood stem cell transplant, or PBST, stem cells are harvested from a donor's blood through a process called apheresis.

Seems this treatment is for severe patients once ARDS has set in.

The Drug used is

RYONCIL™ (remestemcel-L) is an investigational therapy comprising culture-expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor. It is administered to patients in a series of intravenous infusions. RYONCIL is believed to have immunomodulatory properties to counteract the inflammatory processes that are implicated in steroid-refractory acute graft versus host disease by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.