When push comes to shove...... there's very little doubt Theralase will be able to demonstrate significant safety and efficacy clinical outcomes for 20 to 25 patients after their 450 day assessment in 4Q2022 (
FDA approved Keytruda only achieved 18.4% CR at 360 days and the Theralase treatment is far safer and more tolerable.) IMHO this means accelerated approval in 2023 with a corresponding increase in value.
From the MD&A:
"FTD can also lead to Break Through Designation (“BTD”), Accelerated Approval (“AA”) and/or Priority Review, if certain criteria are met, which the FDA has previously defined to the Company for BTD as a complete clinical dataset on approximately 20 to 25 patients enrolled, treated and followed-up, who demonstrate significant safety and efficacy clinical outcomes.
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. "