I notice that the publication of the science (by others) has kicked right in the schedule, but the discussions with TGA for regulatory advice is still current for H1,24. Duthy has committed to advising the market of the minutes from meeting.
A path forward for regulatory approval, (confidential) discussions with Pharmaceutical Benefits Scheme and a Gov't push to curb expenditure o the NDIS would see the planets align in this market. Given it will probably need 2 x Ph3 trials for FDA approval we'd be better off out-licensing this in the US market.
Clearly the 48 month tenure for the autism patients from the first trial is equally as positive.
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