Clinical Trial AccelerationAccelerated pivotal trial topline readout driven by unusually rapid enrollment could provide earlier clarity on efficacy and labeling potential, supporting investor confidence if results are favorable.
First‑in‑class Market OpportunityA randomized registrational study in the intermediate‑risk patient group creates a path to become the first approved adjuvant therapy for that population, opening a substantial commercial opportunity.
Manufacturing And Commercial ReadinessScaling up manufacturing capacity and initiating pre‑launch sales and payer engagement positions the company to meet expected demand and support a smoother commercial launch if approved.