See but patients don't pay for it. You and me and the rest of the pool pay for it.
However AFAIK, the fat lady ain't singing yet. It is obvious to me that the FDA or at least the top level facing the public is sensitive to public pressure and in this case is not willing to take heat and demand real proof.
Thus the requirements for follow on confirmatory trials is a way to split the hair down the middle. OK, we give up (from the FDA commissioner's pov) but we ain't laying down dead yet. Show me the real stuff. Otherwise ...
I can live with this. For one or two drugs. As a policy statement, as a nation, I don't believe we should give in to kind of crap science. But I understand the psychology.
In a way, it is no different than the parents of autistic children. It is hard to accept that it random, ie genetic linked. So Vaccines it is or alien's something or other.
As always, it is OK for somebody else's ox to be gored as long as it is not my own. Sad but always true.