Hi @thevinnys can I confirm my understanding of the Ann today and the timelines for the OSA phase 2/3 trial and next steps?
Q1 2023 file for USA IND with FDA
Q2 to Q3 2023 if no objection from FDA activate trial sites and commence recruitment - 20 to 30 sites with a total of 116 patients involved
Q3 2023 to Q3 2024 (12 months) conduct BA/ BE trials
Q4 2024 to Q1 2025 apply for FDA drug commercial approval
Btw, why is the trial mentioned to be conducted at CMAX while it is conducted across all the trial sites?
Thanks in advance.
(any errors or omissions are my own. No advice)