Launch Pace UncertaintyREMS dynamics combined with typical payer hurdles create the risk of a gradual launch trajectory, which could limit how quickly commercial revenue scales even if clinical demand is strong.
Payer And Authorization HurdlesPrior authorization and certification requirements can delay prescription fulfillment and postpone revenue recognition, weakening near-term sales momentum.
REMS Safety And Monitoring BurdenThe REMS program with intensive liver monitoring and a black box warning introduces additional safety oversight that could deter some initiations and add monitoring costs.