As the old proverb goes, “There’s many a slip twixt the cup and the lip.” As efforts to conduct Phase 3 research into MDMA-assisted psychotherapy for PTSD and psilocybin therapy for depression are being initiated, it is looking quite promising that by 2021 MDMA and psilocybin will be approved as adjuncts to psychotherapy by FDA and potentially by EMA. With promising Phase 2 data, psychedelics have never been closer to being legally approved as adjuncts for psychotherapy. I’ll discuss MAPS’ progress with Phase 3 planning for both FDA and EMA, including the fundamental mistake that the Phase 2 research revealed in my hypothesis in how to design a double-blind study with psychedelics. I’ll highlight some of the key challenges ahead including developing adequate training for therapy providers and meeting the enormous need for psychedelic therapy, gathering information about therapeutic outcomes and adverse events post-approval, obtaining insurance coverage, avoiding sexual misconduct in therapeutic settings, avoiding backlash from drug warriors, managing the relationship with the drug policy reform movement, managing public education and potential advertisements, and the ethics of costs, profits and for-profit businesses.