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US FDA Performance Tracker Rare Diseases Drug Approval Standards

Lessons Still To Learn: Cytokinetics’ Omecamtiv Is Over In The US, But FDA Debriefs Could Inform European Strategy

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Executive Summary

Cytokinetics will not conduct the new trial in heart failure with reduced ejection fraction (HFrEF) required by the FDA’s complete response letter for omecamtiv mecarbil.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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