After reading the announcement again now in detail, it seems like the process for the psychedelics trial will be as follows.
1. Creation of initial clinical trial protocol(Current) 2. Pre-IND meeting with the FDA called. (No Camargo? Maybe we dont need them for this) 3. Clinical Trial Protocol tweaked thanks to FDA feedback. 4. Registration of the Clinical Trial on ANZCTR at Monash. 5. Ethics Approval Submission. 6. Ethics Approval Granted. 7. Recruitment Begins. 8. Trial start. 9. Trial end.
It's going to be a Phase 2 Human Trial too with 72 patients.... Company maker in itself. Wow! If successful.... hundreds of millions added to the MC at first shot, then more to come with every step closer to commercialization.
Not to mention ARDS.... OSA.... TBI.... Remember BOT boasted a >250M MC in its heyday with only a single Phase 1 Acne and In-Vitro Staph results.
Currently IHL is running 4 programs concurrently. 1. Phase 2B OSA Human Trial @ Alfred 2. Phase 2 Psilocybin Human Trial @ Monash 3. ARDS FDA Pre-IND for EUA -> Possible Phase 1/2 Human Trial 4. TBI Pre-clinical In Vivo -> Phase 2B Human.
[REPOST, Anyone new to IHL who hasnt already read the summary post already should if they bought in on the psychedelics announcement and need a summary and catchup as to what else the company is up to.]