Approval AssuranceAn SPA doesn't guarantee approval if the trial is positive, but it's as close as the agency ever gets to this type of assurance.
Data LimitationsThe NDA resubmission package contains only data from the chamber trial, which means that it does not include data from the negative field trial.
Market CompetitionDespite its rarity, the significant disease burden and a lack of competing treatment options makes the PVRL market worth looking at.