Ann: IHL Completes Pre-IND Meeting with US FDA on IHL-675A, page-2

This is the important bit...

"In the written correspondence, FDA provided valuable, multidisciplinary feedback on the proposed clinical development of IHL-675A. Importantly, the FDA confirmed that no further nonclinical studies are needed for the IND application.The FDA also provided specific guidance on what is required for Incannex to submit an NDA via the 505(b)(2) pathway, whereby some of the information required for marketing approval is derived from published studies on the components of IHL-675A and/or the Agency’s findings on safety and/or effectiveness for relevant listed drugs."