Commercial And Regulatory RiskReported revenue shortfalls tied to patient treatment delays, combined with regulatory uncertainty and competitive pressures, highlight risks to the product's market recovery and wider commercial trajectory.
Comparator ValidityThe external control cohort appears to behave differently and may be systematically weaker than the original internal placebo, which can mechanically exaggerate apparent treatment benefits and reduce confidence in outcome validity.
Trial Design IntegrityA planned placebo crossover removed the randomized internal comparator, leaving reliance on external controls and undermining the robustness of efficacy comparisons for regulatory and clinical assessment.