US EditionClene Inc. Advances Regulatory Strategy for CNM-Au8 with FDA Meetings Scheduled for ALS and MS Programs
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Clene Inc. Advances Regulatory Strategy for CNM-Au8 with FDA Meetings Scheduled for ALS and MS Programs
Clene Inc. (NASDAQ: CLNN) has announced significant advancements in its regulatory strategy for CNM-Au8, following a productive Type C meeting with the FDA. The meeting provided valuable feedback on the company’s statistical analysis plan (SAP) for evaluating neurofilament light (NfL) biomarker data from its Expanded Access Protocol for amyotrophic lateral sclerosis (ALS). Clene has since resubmitted a revised SAP and anticipates FDA acceptance …
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