I think someone earlier was confused about why we had secured a supply of MDMA at the same time as working on our own MDMA synthetic analogs.
^ hopefully explains the two sides a bit clearer (nature vs synthetic), why we start with one use it through the cannabis/MDMA special access framework, to gather RWD to inform the dosing and then take that info and apply it to the synthetic that we take through trials.
You don't have to do that we can start with the MDMA synthetics right away. But running a trial of 10 comes at a cost. and slow to react. Where 1+1 you can change every single time low-cost fast results, fast continuous improvement process.
AND the FDA is happy to use the RWD that means our phase 3's can be much smaller as we already have ~4000 others and counting live feed of information for them (they don't need to ask us to run 4 more phase 3 trials each with 300 people so that the numbers get up >2000
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