"The obvious gap in the palliative care toolbox is a tool for the relief of nonphysical suffering, and psilocybin is that tool." "It's really essential that everyone in patients' rights, hospice and the palliative care movement stand up and insist that it be available sooner rather than later."

The FDA has granted the application priority review and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 11, 2024 to make the review determination.

In this article we outline key knowledge gaps that may be imperative for a successful implementation of psychedelic drugs as medicines as identified by members of the European College of Neuropsychopharmacology at the New Frontiers Meeting in Nice (2023)

If MDMA receives FDA approval this autumn (which seems very likely), then the UK Medicines & Healthcare products Regulatory Agency (MHRA) will recognise MDMA within either a 60-day or 110-day timeline. Since the UK has already given MDMA an approval-speeding Innovation Passport, it seems likely that MDMA licensing will follow the 60-day timeline, leading to UK licensing by the end of the year or not long after. Lots of fingers crossed!