RE:RE:RE:RE:RE:RE:RE:RE:RE:Keep patient, maybe we are at last step to the final victory 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 II Treatment, to be the first intravesical, patient-specific, light-activated, Ruthenium-based PDC for the treatment of patients diagnosed with BCG-Unresponsive NMIBC CIS, (with or without recurrent / resected papillary Ta/T1 tumours). 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 clinical data on approximately 20 to 25 patients enrolled and provided the primary Study II Treatment, who demonstrate significant safety and efficacy clinical outcomes.
In 2021, Theralase® completed its first significant milestone of Study II by enrolling and treating (primary Study Treatment) 25 patients.
In 2022, Theralase® completed its second significant milestone of Study II by enrolling and treating (primary Study Treatment) 50 patients.
The Company has submitted a pre-BTD submission to the FDA and based on the FDA's feedback, the Company is currently working with the CSSs, a biostatistics organization and a regulatory organization to update the pre-BTD with clinical data clarifications identified by the FDA. The Company plans to resubmit the pre-BTD submission to the FDA in late 3Q2023 / early 4Q2023 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 support of the grant of a BTD approval in 4Q2023.