CLENE NANOMEDICINE

Gaining insight on Congressional intent regarding Accelerated Approval statute 21 USC SECTION 356 and inconsistencies with 21 CFR Section 314.

Clarifying the discrepancy between statute and FDA regulations regarding use of survivability as a clinical endpoint in the accelerated approval process; Urging FDA alignment between CBER and CDER on regulatory flexibility; and encouraging ability for thorough public review of promising treatments for ALS and other neurodegenerative diseases.

Navigating policy issues that surround FDA approval of company's treatments for neurodegenerative diseases (like ALS, MS, and Parkinson's) through restoration and protection of nueronal health and function, including seeking regulatory flexibility through Accelerated Approval process.