Efficacy Endpoint UncertaintyHigh-resolution imaging signs of mucus clearance have not reliably translated into improved lung function or quality of life, creating uncertainty about the program's ability to meet pivotal efficacy endpoints.
Management Credibility And ExecutionUneven execution and repeated setbacks have eroded management credibility, which can sustain a valuation discount until consistent delivery is demonstrated.
Trial Enrollment And Statistical Power RiskDividing a limited patient pool into dose-specific subgroups risks producing underpowered cohorts, increasing the likelihood that trials will fail to detect true treatment effects due to variability.