Ann: Phase 1 trial commences Q1, 2022 for Emyrias ultra-pure CBD, page-8

phase 1 may be very simple/quick - just need human safety data. Phase 3 will be efficacy. If they are treating “generalised psychological distress” their outcome measure may just be simple rating scales.

in other words, the drug is quite safe so you could really consider a lot of the phase 1 work to have been done in other trials, TGA won’t care so much they’ll just want to know this particular product is tolerated.

for the phase 3, efficacy for such a broad indication where we are looking for an immediate effect should also be quite quick to assess. Outcome measure easy (simple questionnaires likely) - recruiting could be streamlined through emd clinics. Probably only needs to run for a few months, then crank out the stats etc.