Phase 3 trial expected to begin enrolments in Q1 2024 barring no...

Phase 3 trial expected to begin enrolments in Q1 2024 barring no further delays. 600 patients being enrolled, 100 patients enrolled a month would be an incredibly good result, so optimistically my guess would be 6 months to complete enrolment. 16-week primary endpoint readout, followed by a month of data lockout and another month or two of generating the reports of the results and preparing them for an announcement along with the "what next" plan.

If they were able to start the trial in Feb 2024, you're looking at getting results of the full trial probably by Feb 2025 earliest. If the company announces enrolment milestones (which they hopefully will but they haven't been the best with keeping shareholders informed to date, seeing as they gave no real explanations to why the trials are now starting in 2024 after being slated for 2022 start at IPO), then you can keep track of this yourself by looking forward 7 months (4 months for primary endpoint, 3 months for analysis and report writing) from when they announce the final patient has been enrolled.

I also think their forward looking statement saying they're still confident the $21m in cash is enough for the phase 3 trial is incredibly ambitious, and potentially misleading. These trials are expensive, and 600 patients is a tall order. When I say misleading, it sounds like they're saying they won't need to raise any cash before the end of the trial. I'm expecting they will plan to release some interim results from maybe the first 100-200 patients in Oct-Nov 2024 and off the back of that (assuming the interim results are positive) raise money under the pretense it will be needed for possible production ramp up and application to the FDA.

I've been keeping an eye on this since it listed and shareholders have been too forgiving on the lack of real updates from the company to explain the delays in this program. The only way the company has acknowledged these delays is by quietly pushing back the expected starting date of the Phase 3 in each of their reports. It's no wonder the broader market seems to want nothing to do with this. Will keep watching to see if they can finally stick to their start date and manage to keep shareholders updated on progression.