When last we were informed ! Tick Toc Tick Toc Break Through Designation Update: In 2020, the FDA granted Theralase® Fast Track Designation (“FTD”) for Study II. As a Fast Track designee, Theralase® has access to early and frequent communications with the FDA to discuss Theralase®’s development plans and ensure the timely collection of clinical data to support the approval process. The accelerated communication with the FDA potentially allows, the Study Procedure, to be the first intravesical, patient-specific, light-activated, Ruthenium-based small molecule for the treatment of patients diagnosed with BCG-Unresponsive NMIBC CIS, (with or without recurrent / resected papillary Ta/T1 tumours). FTD can lead to Break Through Designation (“BTD”), Accelerated Approval (“AA”) or Priority Review, if certain criteria are met, which the FDA previously defined to the Company for BTD as clinical data on approximately 20 to 25 patients enrolled and provided the primary Study Procedure, who demonstrate significant safety and efficacy clinical outcomes.
To this list, the FDA has added: Post Study II Monitoring of Response and Central Pathology Laboratory Review, as further defined above. The Company is currently working with the CSSs, a biostatistics organization and a regulatory organization to update the pre-BTD submission with clinical data clarifications identified by the FDA. The Company plans to resubmit the pre-BTD 6 submission to the FDA in 4Q2024 for FDA review of these clarifications. Once the pre-BTD submission has been accepted by the FDA, the Company
plans to compile a BTD submission for review by the FDA in 1Q2025 in support of the grant of a BTD approval. Theralase® has
received the majority of the clinical data from the CSSs with a high percentage of patients showing a duration of their CR beyond 450 days, with some patients demonstrating CR for up to ≥ 3 years, post receiving the primary Study Procedure. financialReportViewer