Clene Inc. (NASDAQ: CLNN) Announces Plan to Submit Briefing Book to FDA Preceding Type C Interaction
Clene plans to submit a briefing book to the U.S. Food and Drug Administration by July 13 as Part of Overall Process to Support Approval for CNM-Au8(R) for Treatment of ALS Type C interaction is 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 Clene (NASDAQ: CLNN) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage…