3 ms·
This happened yesterday (Tuesday 29th November 2016) afternoon. There was a meeting with the FDA where they would give a verdict, and they gave approval during
by arikr 10y ago
This happened yesterday (Tuesday 29th November 2016) afternoon. There was a meeting with the FDA where they would give a verdict, and they gave approval during that meeting.
Information explaining the significance from fruitsforhire
> Okay so here's a little background information on what this specifically means. It has taken 30 years to get to this point. MAPS has been around since 1986 with the main purpose of getting MDMA through the legal prescription system in the United States. Some extremely talented and dedicated individuals have made it their life goals to study MDMA (and other drugs as well) and to get them through the absurd regulatory hurdles Western nations have enacted since the War on Drugs.
> Phase 1 trials FDA trials for MDMA were greenlit in 1992, and Phase 1 trials are simply trials to assess safety in a small handful of individuals. It's just the step after animal safety trails. Preparation for Phase 2 and then subsequently Phase 2 is what has been going on for a decade or so which is small-scale human trials meant to start studying the actual effectiveness of the drug. It's all extremely expensive and complicated work building the foundation for Phase 3 trials which are absolutely massive in scale compared to anything else before at roughly 10 times as many people involved as Phase 2. It is one of the toughest and most rigorous prescription drug regulatory systems in the world. Phase 3 is going to take many years, and it'll cost tens of millions of dollars.
> Most drugs never even make it to Phase 2, but on top of that most never make it through Phase 3 either. This will be the last crucial many years and many millions of dollars that stand in the way of MDMA becoming a legal prescription medication.
> If you believe in this cause and have money to spare then I highly recommend donating. Phase 3 trials cost an immense amount of money to fund. MAPS is a non-profit organization, and the only one of its kind in the world.
> More information can be found at maps.org and mdmaptsd.org