Clinuvel Pharmaceuticals has announced that the US Food and Drug Administration (FDA) Division of Dermatology and Dental Products has set a new Prescription Drug User Fee Act (PDUFA) goal date of 6 October 2019 to provide it with more time for a full review of the submission of its SCENESSE® scientific dossier.
Analysts at Moelis note that while any delay around FDA approval is disappointing, given it will push back first sales in the US by at least 3 months, they are not concerned that the hold up is a sign of anything sinister. Rather its likely only a timing issue.
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