Financing And Execution RiskOngoing clinical development paired with current cash burn may require the company to seek additional funding, raising the possibility of dilution or execution risk if financing terms are unfavorable.
Safety And Tolerability RiskCombining multiple agents introduces safety risks that could lead to tolerability issues or toxicities, potentially limiting trial success or clinical uptake of combination regimens.
Trial Design And Statistical InterpretationAllowed patient crossover in the pivotal trial may complicate overall survival interpretation, creating reliance on adjusted analyses that could be viewed as less definitive by regulators or investors.