Extina "Not Approvable" Decision Reflects Non-Superiority Over Placebo
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Extina "not approvable" due to lack of superiority to placebo foam, Connetics says; the ketoconazole foam for seborrheic dermatitis did meet primary endpoint of non-inferiority to active comparator. Firm will decide whether to pursue approval or switch to other pipeline projects. An additional clinical trial would not require significant changes and would be quick to complete, company notes
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