RE:RE:RE:RE:RE:RE:BTD and pre-BTD overview
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.
Add to the previous analysis that all the foregoing acts (compile report, grant of BTD and completion of 450 day assessment) were further "subject to" (i.e., conditioned on completion of) all "required assessments and biostatistical review and analysis."
Meaning: the "expected in Q42022" language is utterly meaningless because there are multiple other things that also have to be completed even after they have 450 day data for 25 patients which could also throw the timeline off.
Further add that we don't know if they have chosen to exclude early patients and ONLY use data for 25 patients treated with the optimized dose...
So that's like 5-6 points of uncertainty and ambiguity in the timeline.
I.e., 4Q2022 = meaningless.
An update would take, at most, 15 minutes to draft and publish.