The company plans to complete the submission in the coming months, bolstered by findings from its PARADIGM clinical program. During the consultation, officials reviewed a comprehensive package that included a 14.9-month median survival benefit and the achievement of a prespecified TDP-43 biomarker endpoint. These results, combined with expert clinical perspectives, form the core of the evidence NeuroSense believes will address the critical unmet needs of the ALS community.

PrimeC, an extended-release combination of ciprofloxacin and celecoxib, is engineered to address multiple disease pathways, including neuroinflammation and oxidative stress. While preparing for the Canadian filing, the company is also moving forward with its broader development strategy, including an upcoming pivotal Phase 3 trial in the United States. CEO Alon Ben-Noon described the regulatory progress as a milestone, noting that the consistency of the clinical data has strengthened the firm's confidence in the therapy's potential to slow disease progression.