Yeah putting myself in the shoes of someone with this disease or a loved one with this disease I would be so incredibly angry that we weren't allowed to try something when the alternative is certain death
I think you could mitigate some of the problems by making the drug company pay for the treatment before approval.
It's the prisoner's dilemma. Or more succinctly:
Take something and possibly live, or take nothing and certainly die.
There is a lot of money to be made selling snake oil to the desperate, so we definitely want regulation…