Evidence Of Disease-modifying BenefitConsistent non-seizure improvements across communication and adaptive behavior measures, backed by KOL validation and supportive Phase 1/2 data, strengthen the case for a broad, disease-modifying label and higher commercial value.
Regulatory Engagement And Expedited PathwayBreakthrough Therapy designation combined with planned FDA meetings and a rolling submission strategy increases the potential for expedited review or earlier access if regulators are receptive.
Trial Enrollment AccelerationPhase 3 EMPEROR enrollment progressing faster than expected reduces execution risk and shortens the path to a pivotal efficacy readout, supporting a quicker regulatory filing trajectory.