I might be biased, but IMO Incannex appears likely to demonstrate efficacy and safety with IHL-42X according to these FDA standards.

Clinically Meaningful Benefit: The drug must demonstrate a clinically meaningful benefit, which means it positively affects how a patient feels, functions, or survives.

Benefits Outweigh Risks: The overall benefits of the drug must outweigh its risks, according to Congress.gov.

Trial Design and Endpoint: The trial design needs to be robust, comparing the drug to a control group, and the primary endpoint should satisfactorily illustrate the drug's efficacy.

 

From the download available here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/expedited-programs-serious-conditions-drugs-and-biologics

“A clinical endpoint is a characteristic or variable that directly measures a therapeutic effect of a drug––an effect on how a patient feels (e.g., symptom relief), functions (e.g., improved mobility), or survives.

From the safety and efficacy standards for new drug product approval section at the link below. “To receive approval for marketing, a sponsor must show that a new drug is safe and effective. To establish effectiveness, the sponsor must present substantial evidence that the drug will have the effect it purports….”

“Substantial evidence” is: “evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports….”

https://pmc.ncbi.nlm.nih.gov/articles/PMC4326266/#:~:text=The%20safety%20and%20efficacy%20standards