RE:RE:RE:RE:RE:BTD and pre-BTD overview FPGstock wrote
2) Break Through Designation Update. In 2021, Theralase® completed its first significant milestone of Study II by enrolling and treating 25 patients. The Company will compile a clinical data report for submission to the FDA in support of the grant of a BTD approval after completion of the 450 assessments for 25 patients, expected in 4Q2022, subject to the CSS’s availability to complete all required assessments and biostatistical review and analysis.
Within that statement its clear the data wasn't known and feedback from the FDA hadn't been given to Theralase plus one word of caution that a few ignored "expected" which I remember thinking, wait and see. For me the only clear signal from the company was recently that BTD would be in a few months.