Extina “Not Approvable” Decision Reflects Non-Superiority Over Placebo
This article was originally published in The Pink Sheet Daily
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.
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“The spin-off will establish two separate companies, a fully integrated, pure play, eye health company built on the iconic Bausch Health brand and a long history of innovation, and an international diversified pharmaceutical company with leading physicians in gastroenterology, dermatology, aesthetics, neurology and an international pharma business,” says CEO Joseph Papa.