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NeuroSense Secures Key FDA Meeting to Advance its Phase 3 ALS Trial and NDA Submission
NeuroSense Therapeutics (NASDAQ: NRSN) has secured a Type C meeting with the FDA on November 6, 2024, to discuss the design of its Phase 3 clinical trial for PrimeC, a potential ALS treatment. The meeting will focus on finalizing trial design and reviewing NDA submission readiness.
PrimeC has demonstrated significant results in reducing disease progression markers. The company plans to submit its regulatory dossier to Health Canada in Q2 2025, with a decision expected by Q1 2026. The potential Canadian market opportunity is estimated at $100-150 million in annual revenue. Clinical findings showed PrimeC reduced disease progression (p=0.009) and improved survival rates by 43% compared to placebo.
PrimeC has demonstrated significant results in reducing disease progression markers. The company plans to submit its regulatory dossier to Health Canada in Q2 2025, with a decision expected by Q1 2026. The potential Canadian market opportunity is estimated at $100-150 million in annual revenue. Clinical findings showed PrimeC reduced disease progression (p=0.009) and improved survival rates by 43% compared to placebo.
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