Our team is diligently preparing to submit a clinical protocol, and Statistical Analysis Plan, for the FDA's review. Following alignment with the FDA's expectations, we will formally submit our SPA request. We anticipate making this submission in February 2024. The FDA's response is expected within 45 days of submission.
The process is long, i do not forsee results before mid 2025 earliest. Myself i am long ago out, and only following the company for academic reasons.