[lukeschlather]

Not at all. It's like the FDA approving a drug with a 100 mg /day dose, and a company rolling out a plan for 200 mg /day dose, and trying to convince the FDA that 200 mg is safe. Unless they actually get approval for 200 mg, they're not going to be able to ship.

[roc]

And continuing the metaphor: having the FDA say "If your self-funded trials say it's Ok, then we're satisfied".

The funny part is, some times, that's how the FDA does work. That's how we wound up with all those depression drugs that were only as effective as a placebo.