"What could be benefited by not approving it with all the pertinent disclaimers about effectiveness?" Let's say it is approved, with all pertinent disclaimers.

"What could be benefited by not approving it with all the pertinent disclaimers about effectiveness?" Let's say it is approved, with all pertinent disclaimers. And that it has no side effects (which seems unlikely). With little evidence of effectiveness, insurance, public or private, will not pay for it. They have every right, and at least a fiduciary responsibility not to. But you are desperate, and you are willing to pay $130/day for the drug. What happens if it doesn't work? (As you say, the list of things that don't work is extensive.) Are you going to post on the net, "Our mother's medication didn't work and literally bankrupted us, but it's our fault"?