I understand the purpose of appeals and that we rarely hear about things that are not appealed. But I don’t think either the FDA or court system are functioning when people and companies go in front of a decision-making body knowing they’re going to lose and viewing the ruling as the real starting gun.
I’m baffled. At no point did I say the denial was the wrong decision. The best MAPS can do here is start over again at Phase III but this time figure out solutions to the fatal flaws that sank the application – and maybe not let anyone get sexually assaulted in the process.
The biggest hurdle I see is blinding. There’s simply no way to know you’re not rolling, whether you’ve done MDMA in the past or not, so placebo is pointless.
oh okay, sorry, i took away a different impression from your OP talking about how the FDA process is flawed due to appeals being the starting point (which very well may be true) - but including that with this article made it seem like you felt that way about this particular incident (e.g. the link was supporting evidence), not that the commentary on the FDA process was it’s own, unrelated thing
glad to hear that we’re in agreement about the denial, though
i can’t really comment on the process, i’ve never taken mdma myself. that said, you say there’s no way you wouldn’t know you’re on it, but there’s a number of substances out there where you’d think that would be the case, but it isn’t (think like, the stereotype of people acting drunk with little / no alcohol, just thinking they had it). also, the dosages may be lower / less obvious, although i have no idea what the dosages used for recreational use vs for therapeutic use are here
I recall seeing that the therapeutic dose was pretty close to if not the same as recreational, which would be 100 mg.