Ann: Trading Halt, page-57

To KGDN, you can still watch it.

Ma420
He spoke a lot about the neuren model. It's obvious that they want a partner.
And he pretty much dismissed FDA approval. He specifically said they are focussing on Australia.

And (not his exact words) but if they can get 'special approval' they are looking at 18 months for product approval.
But he did point out something I had pondered. A possible requirement for another trial being requested by the TGA.

Also note: and this goes back to a previous suggestion by you. They are not looking for orphan approval in ASD.
As I said, they won't get it.

The market is just too big. Go read up on typical approvals for orphan status applications.