Curated News
By: NewsRamp Editorial Staff
July 19, 2024
Clene Inc. Submits Briefing Book to FDA for CNM-Au8 ALS Treatment Approval Process
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- Clene's submission to the FDA for approval of CNM-Au8(R) for ALS treatment gives them a potential edge in the neurodegenerative disease drug market.
- The submission includes new post-hoc analyses of data and addresses comments from the FDA during a previous meeting.
- CNM-Au8 has the potential to combat neurodegenerative diseases, making the world better by offering hope to ALS patients and their families.
- Clene's briefing book submission to the FDA by July 13 precedes a Type C interaction, aiming to obtain feedback on the potential pathway for NDA approval for CNM-Au8 as a treatment for ALS.
Impact - Why it Matters
This news is important as it highlights the efforts of Clene Inc. to seek FDA approval for CNM-Au8 as a treatment for ALS. If successful, this could potentially lead to a new therapeutic option for patients suffering from this debilitating neurodegenerative disease.
Summary
Clene Inc. and its subsidiary Clene Nanomedicine Inc. plan to submit a briefing book to the FDA by July 13, as part of the process to support approval for CNM-Au8 as a treatment for ALS. The Type C interaction is aimed at obtaining FDA feedback on the potential pathway for a new drug application for CNM-Au8, and the briefing book includes new post-hoc analyses of data from completed clinical trials.
Source Statement
This curated news summary relied on this press release disributed by InvestorBrandNetwork (IBN). Read the source press release here, Clene Inc. Submits Briefing Book to FDA for CNM-Au8 ALS Treatment Approval Process
