Data Robustness ConcernsSkepticism persists that single-arm IGNYTE data may be insufficient for accelerated approval, which could lead regulators to demand more rigorous, randomized evidence.
Regulatory Setbacks And Trial RequirementsThe prior Complete Response Letter citing patient heterogeneity and study design gaps raises the risk that regulators could require additional or rerun studies, increasing development costs and timelines.
Regulatory Volatility Impact On ValuationOngoing back-and-forth with the agency creates regulatory volatility that could depress the stock if further setbacks occur or if approval timing remains uncertain.