[devmor]

Your imagined situation relies on the supposition that the new treatment is "promising" - how often do you think this is the case?

A person facing death from disease is desperate, and desperate people are easily taken advantage of. This is part of the reason the FDA exists - to protect desperate people from being ripped off.

The FDA can and should prevent unproven medicines that are not ready for human trials from being used without due diligence.