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Stroke is also the only neurologic condition with an FDA-accepted objective functional endpoint (Fugl-Meyer Assessment Score, including objective motor metrics), providing a validated, quantitative efficacy measure that helps de-risk approval

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Various transgressions are detailed in the letters, including implying that medicines were FDA-evaluated for safety or FDA-approved, using phrases like "clinically proven" in promotions, claiming to be the manufacturer when in fact another organisation is making the drugs, and misleading advertising

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