Before you can even commence a clinical trial, there’s multiple steps to work through in preparation for the trial after the appropriate regulatory agency has given approval. These can take up to 12 months to work through but the correct trial set up is critical to the overall success of the trial. 

Cynata Chief Medical Officer Dr Jolanta Airey outlines the process here: https://www.theaustralian.com.au/business/stockhead/asx-stocks-on-long-winding-road-from-fda-to-clinical-trial-in-2023/news-story/4bb2bc9e9c31e357cc6ab63fe8507e47