Ann: AusCann to Accelerate Human Drug Development Program, page-10

For clarity, the engagement is to outsource initial desktop research to evaluate opportunities to accelerate human drug development, by leveraging the data and assets that AusCann has already generated to date, in specific therapeutic areas that AusCann has pre-determined.

The team that we have within AusCann are highly capable, having designed, managed and executed significant cannabinoid-based research to date, including multiple in-vitro/in-vivo toxicological studies, randomised placebo-controlled clinical trials, pharmacokinetic studies and various other research activities in both human and animal across Canada, Europe, U.S and Australia.

This work has led to the submission of the first Investigational New Animal Drug file with the FDA-CVM for our cannabinoid-based veterinary drug program in the U.S, and the submission of the first cannabinoid-based regulatory dossier with the APVMA for an Australian veterinary medicine containing cannabidiol.

Outsourcing the initial gap analysis to a highly specialised Clinical Research Organisation enables AusCann to quickly gather a broad cross-section of scientific and regulatory input from industry experts, while allowing the AusCann team to remain focused on our upcoming milestones, which are our priority.