Development And Regulatory UncertaintyUncertainty about timing of additional dosing data, futility assessments, and regulatory interactions for the Emi‑Le program increases development risk and could delay progress toward potential approvals.
Physician Prescribing HesitancySome clinicians remain hesitant to prescribe Ojemda for certain patient groups, which could limit market penetration despite available clinical evidence.
Safety Profile — Growth SuppressionA significant share of patients experienced marked slowing of growth, including severe decreases in growth velocity, which may remain a barrier for clinician and caregiver acceptance.