Ongoing interactions between the US Food and Drug Administration (FDA) and CLINUVEL’s scientific teams continue to take place as the final outcome date of October 6, 2019 approaches. This date has alreayd been extended from May 31st to October 6th. In the latter half of the scientific review, the FDA will attempt to address substantive review issues which have not yet been covered by its committee members. At this stage, the FDA will use its time to gain a broader insight of risks and benefits while reserving the right to identify new review issues that may trigger an extension of the Prescription Drug User Fee Act (PDUFA) goal date. There is no indication that the current PDUFA date cannot be met; it is CLINUVEL’s expectation that October 6th will remain the current PDUFA goal date for an outcome to be provided.
Read Clinuvel's August Newsletter at https://www.clinuvel.com/wp-content/uploads/2019/08/CLINUVEL-Communique-VI.pdf