alt Hacker NewsThat's assuming that the Venn diagram of "proving that it's safe and effective" and "following the approval process" is one circle and there are no unnecessary requirements.
Which is demonstrably false, since e.g. the US and Europe have different requirements and neither is a subset of the other. If we accept that they both require adequate proof of "safe and effective" that means they also both impose unnecessary requirements, since otherwise the requirements would fully overlap.
1) No, not even theoretically. Since "prove" means different things to different organizations.
2) I didn't say there are no additional requirements. For example, you have to fill out some paperwork. I said they are trivial compared to actually making a drug that works and proving that it works. Drugs do not die because of the approval processes, they die because it's unfathomably hard to make drugs that work and then to prove that they work.