Ann: Phase II/III ASD Trial Successfully Meets Primary Endpoint, page-8

Pretty sure they are going for TGA Approval for the Autism Spectrum Disorder Treatment,
TGA is like the Aussie version of FDA Approval,
And should be rather straight forward seeing other cannabis products
have already been approved here.

But yeah fairly sure it is FDA for the others.
Generally FDA Approval is done after Phase III.
Although their have also been cannabis products approved there,
Which should make it easier as well.

Also as @miskamouse recently posted the US may be moving Cannabis to Schedule III,
Which some legal experts have suggested doctors and dispensaries will be able to dispense Cannabis products direct to patients without a prescription of FDA Approval.

This could make it a lot easier for NTI if it occurs....