Market Access And Adoption PressurePhysician preference for lower-cost established therapies and reimbursement constraints could limit uptake to more severe patients, reducing the drug's commercial reach.
Mechanism-of-action UncertaintyUnresolved questions about how the drug eliminates unbound copper, including prior inability to explain the mechanism, may undermine regulatory confidence and scientific acceptance.
Regulatory Process RiskRegulators could request additional studies or engage in labeling negotiations, creating potential delays or complications for the approval pathway.