Australian biotechs are high on optimism about the multi-billion dollar potential of psychedelic treatments for mental health, but regulators still have big question marks.
These businesses are bullish on the long-term applications of the drugs, with many saying that a change in regulation of the substances will signal to the market that the regulator is open to innovation. Undeterred by the first TGA decision, Mind Medicine Australia went back to the drawing board and has made a second application to relax regulation of psychedelics that includes additional information and new safety provisions. The regulator has once again opened consultation on the issue.
Emyria chief executive Michael Winlo says companies in the medicinal cannabis space are carefully working to deliver evidence of their products to the TGA. Winlo says supporters of a reclassification of the drugs are largely looking for a recognition that there’s evidence that substances like psilocybin have a therapeutic effect.
“Emyria is committed to participating in this process and help meet the patient need for new treatments while also helping gather the required clinical evidence with patients.”