Extina “Not Approvable” Decision Reflects Non-Superiority Over Placebo
This article was originally published in The Pink Sheet Daily
Executive Summary
Connetics’ ketoconazole foam for seborrheic dermatitis was not superior to placebo foam in a pivotal study, although it met the primary endpoint of non-inferiority to an active comparator. The company will decide whether to pursue approval in relation to other pipeline projects.