Its also probably worth noting that IND submission & FDA...

Its also probably worth noting that IND submission & FDA approvals are for clinical trials in the US. This tells me that this where most likely where our human trials will take place, maybe in conjunction with the University of North Carolina?

In Australia, we dont require IND submissions. The below is taken from Southern Star Research website:

Rapid Clinical Trial Approvals

The streamlined clinical trial approvals process in Australia allows your study to be approved in less than 8 weeks without requiring an IND.

The Human Research Ethics Committee (HREC) process takes 4–6 weeks on average. Site governance documents are submitted concurrently and typically take 6-8 weeks. Clinical Trial Notification (CTN) is the final step in the approvals process. Confirmation from the TGA is usually received within 2–3 days, allowing you to formally commence your study.

https://southernstarresearch.com/clinical-trials-in-australia/#:~:text=The%20streamlined%20clinical%20trial%20approvals,typically%20take%206%2D8%20weeks.

Hopefully we look at doing the clinical trials in both the US & Australia.