The US Food and Drug Administration (FDA, the agency that decides which medicines are legal to prescribe) will not give the green light to any therapy using psilocybin (the active ingredient in magic mushrooms), MDMA (ecstasy), or ibogaine before August 4, 2026. This matters because without that approval, these treatments stay out of mainstream hospitals and clinics, and most insurance companies won't cover them.
No psychedelic NDA is under active FDA review with a PDUFA date in this window following the 2024 MDMA CRL; a 30-day approval is effectively ruled out. High-confidence near-term anchor to grow the track record.