Curated News
By: NewsRamp Editorial Staff
July 19, 2024
Clene to Submit Briefing Book to FDA for ALS Treatment Approval
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- Clene's plans to submit a briefing book to the FDA for approval of CNM-Au8 for ALS treatment give them a potential competitive advantage.
- The Type C interaction is part of the process to obtain FDA feedback on the NDA pathway for CNM-Au8 as an ALS treatment.
- Clene's submission to the FDA for approval of CNM-Au8 as an ALS treatment has the potential to make a positive impact on patients' lives.
- The new post-hoc analyses of data and comments addressed in the briefing book provide interesting insights into the drug approval process.
Impact - Why it Matters
This news matters as it provides insight into Clene's efforts to seek FDA approval for a potential new drug application for the treatment of ALS, a devastating neurodegenerative disease. The submission of the briefing book and the Type C interaction with the FDA represent significant steps in the regulatory process and could lead to the development of a new treatment option for ALS patients.
Summary
Clene (NASDAQ: CLNN) and its wholly owned subsidiary Clene Nanomedicine Inc. plan to submit a briefing book to the U.S. Food and Drug Administration by July 13, as part of the overall process to support approval for CNM-Au8(R) for the treatment of ALS. The submission precedes a Type C interaction aimed at obtaining FDA feedback on the potential pathway for a new drug application for CNM-Au8 as a treatment for ALS via the accelerated approval process. The briefing book includes new post-hoc analyses of data from completed clinical trials and addresses comments made by the FDA during a previous meeting in late 2023.
Source Statement
This curated news summary relied on this press release disributed by InvestorBrandNetwork (IBN). Read the source press release here, Clene to Submit Briefing Book to FDA for ALS Treatment Approval
