Does this help? From the investor hub.H10:49AM 09/04/2024What...

Does this help? From the investor hub.

H

10:49AM 09/04/2024

What does “commence phase 2/3 in H1” mean?

Hi Michael,

safe travels to the US and I am sure this trip will yield some excellent outcomes as did your last trip to Europe.

The statement has been made that we are working toward commencing the phase 2/3 trial in H1 of CY2024.

What does commencing actually mean?

Is it a signed contract with the trial lead organisation?

is it filing of the trial registration?

Is it selection of trial lead org?

is it approval from a HREC?

is it recruiting?

I fully understand there are a huge number of variables in play so this could very easily slip a little and this is intent rather than promise.

Need to get my expectations under control.

Cheers
Alan

ASXAA

11:55PM 12/04/2024

Hi Alan, great questions! The aim is to have HREC approval at our lead site in Australia by the end of H1 2024. This would typically signify commencement in my eyes. All the other start up activities are in full swing, protocol finalisation, selection of clinical CRO, manufacturing of clinical supplies, etc. Exciting times ahead. From my adventures in the US I’m hearing there’s not a lot of competing studies out there at the moment or planned. That will help