NeuroSense Therapeutics Ltd., a biotechnology company specializing in treatments for neurodegenerative diseases, has announced an upcoming Type C meeting with the U.S. Food and Drug Administration (FDA) scheduled for November 6, 2024. The meeting will focus on finalizing the Phase 3 clinical trial design for PrimeC, NeuroSense's lead drug candidate for Amyotrophic Lateral Sclerosis (ALS), and discussing the company's readiness for a New Drug Application (NDA) submission. NeuroSense also plans to submit a regulatory dossier to Health Canada in the second quarter of 2025, with a decision on commercialization expected by the first quarter of 2026. The company estimates the potential annual revenue for PrimeC in Canada to be between $100 million and $150 million. PrimeC has shown promising results in clinical trials, including a significant reduction in disease progression and improved survival rates. The company will provide an update on the FDA meeting once the minutes are received, approximately one month after the meeting.

NeuroSense Therapeutics Ltd., a biotechnology company specializing in treatments for neurodegenerative diseases, has announced an upcoming Type C meeting with the U.S. Food and Drug Administration (FDA) scheduled for November 6, 2024. The meeting will focus on finalizing the Phase 3 clinical trial design for PrimeC, NeuroSense's lead drug candidate for Amyotrophic Lateral Sclerosis (ALS), and discussing the company's readiness for a New Drug Application (NDA) submission. NeuroSense also plans to submit a regulatory dossier to Health Canada in the second quarter of 2025, with a decision on commercialization expected by the first quarter of 2026. The company estimates the potential annual revenue for PrimeC in Canada to be between $100 million and $150 million. PrimeC has shown promising results in clinical trials, including a significant reduction in disease progression and improved survival rates. The company will provide an update on the FDA meeting once the minutes are received, approximately one month after the meeting.