"The physicians using it believe it does work" Some physicians...

"The physicians using it believe it does work"

Some physicians might believe it works but most might be just giving it a shot incase it might help and probably won't do any harm. But it's expensive so that's potentially a very costly punt.

"There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition"

Well that's also not correct. There are numerous unapproved therapies for children, but Remestemcel is also unapproved so they are all equal in that respect. And there is quite a lot of literature detailing both their side effects and efficacy in different doses and circumstances, but it's probably not true that any one treatment can be regarded as a standard of care.