NeuroSense Completes PrimeC Pre-NDS Process and Advances Toward December 2026 Filing with Health Canada
NeuroSense completed the Pre-NDS process with Health Canada for its ALS therapy PrimeC, targeting a December 2026 filing for the New Drug Submission. Health Canada aligned on the content and structure of the submission and indicated no concerns with the proposed timeline. The filing will be supported by Phase 2b data from the PARADIGM program, which demonstrated a statistically significant ~15-month median survival benefit.
Key figures
- Guidance
- Targeting December 2026 for filing of New Drug Submission (NDS) for PrimeC with Health Canada
- Phase2b p value
- 0.0037
- Phase2b hazard ratio
- 0.35
- Us als annual burden
- $1 billion
- Canadian als prevalence
- over 3,000
- Canadian als incidence annual
- approximately 1,000
- Standard review timeline days
- 300
- Phase2b survival benefit months
- ~15-month median
AI analysis
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