Not the OP, but the FDA evaluates safety and efficacy. They tend to put more focus on the safety vs the efficacy, so its risk reward may be overly conservative

Not the OP, but the FDA evaluates safety and efficacy. They tend to put more focus on the safety vs the efficacy, so its risk reward may be overly conservative if you are dying. Its also an organization that is susceptible to political influence and bribery. For example look into the approval of Oxycontin and the lack of approval of European sunscreens.