Data Analysis Milestones: If the trial includes predefined data analysis milestones (such as interim analyses), the IRB may conduct reviews around these milestones to assess the emerging data.
Assuming - November 2023 Start; Interim analysis February, May, November 2024.
I assume these milestones will be part of the motivation for the re-domicile to the USA; (in November) to release these results to the broader USA market starting in February
The question for me will be if it is a Phase 2/3 over 12 months when does it evolve from Phase 2 to Phase 3