Clinical Trial RequirementsThe agency is seeking extensive safety data, requiring over 300 and 100 patients for six- and twelve-month studies, respectively, which could delay the drug's development.
Financial ImpactDue to anticipated delays in cytisinicline's approval and launch, the price target for the company has been revised downwards from $35 to $25.
Regulatory ConcernsFDA insists on a longer-term exposure study to further validate the safety profile of cytisinicline, potentially impacting approval timelines.