Development Timeline And CostsSafety signals combined with lack of expedited pathway may necessitate additional studies or protocol changes, which could delay pivotal trials and increase development expenses.
Regulatory Designation RiskRegulatory authorities declined expedited designation due to expectations of a clear and substantial benefit over existing therapies, increasing uncertainty around accelerated approval options.
Safety ProfileA notably higher rate of severe neutropenia in the drug arm raises tolerability and safety concerns that could affect trial acceptability and clinical adoption if not mitigated.