I’m trying to understand your point. This drug is for people with metastasized cancer. I’m comfortable with fast tracking it, because what’s exactly the harm of letting desperate people try something that seems likely to help a lot?

Also, the risk profile is sort of the inverse of a covid vaccine where everyone was supposed to take it.

The FDA article lists 5 reasons the pilot of the pilot is only for the non controversial one that is not even listed in a way that maximizes its risk/benefit requirements.