NeuroSense Secures Key FDA Meeting to Advance its Phase 3 ALS Trial and NDA Submission
NeuroSense Therapeutics Ltd. (NRSN)
Company Research
Source: PR Newswire
Meeting discussion to focus on finalizing Phase 3 study design and NDA readiness, ensuring a clear regulatory path for submission based on trial successParallel preparations in Canada: NeuroSense plans to submit its dossier in Q2 2025, with a regulatory decision on commercialization expected by Q1 2026CAMBRIDGE, Mass., Oct. 28, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced it is scheduled for a Type C meeting with the U.S. Food and Drug Administration (FDA) to discuss the design of its upcoming Phase 3 clinical trial for PrimeC, a potential treatment for Amyotrophic Lateral Sclerosis (ALS). The FDA Type C meeting, scheduled for November 6, 2024, will focus on finalizing the design of the Phase 3 trial, a pivotal step toward securing approval for the drug. NeuroSense will also review its readiness for a future New Drug Applic
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News
- NeuroSense Therapeutics to Participate in the 2024 International Symposium on ALS/MND [Yahoo! Finance]Yahoo! Finance
- NeuroSense Therapeutics to Participate in the 2024 International Symposium on ALS/MNDPR Newswire
- EXCLUSIVE: Nano-Cap NeuroSense Schedules FDA Meeting To Advance Lead Program And Marketing Application Submission [Yahoo! Finance]Yahoo! Finance
- New Analysis Shows PrimeC Significantly Improves Key miRNAs in ALS PatientsPR Newswire
- NeuroSense Advances Plans for Early Commercialization of Groundbreaking ALS Treatment in Canada, Provides Further UpdatesPR Newswire
NRSN
Sec Filings
- 11/19/24 - Form F-1
- 11/12/24 - Form 6-K
- 10/31/24 - Form 6-K
- NRSN's page on the SEC website