I believe it’s being approved for compassionate use.
CC
“I believe it’s being approved for compassionate use.”
Yes.
It’s called Expanded Access.
Because it is approved and used, it technically does not need expanded access to be used, but this is the FDA saying they are not against using it for this purpose, which is important.
Basically, a doctor now doesn’t have to worry about a malpractice suit if he uses it to treat a patient.