Evidence RobustnessLimited clinical experience increases the chance of unforeseen safety issues or variable treatment responses as the program expands into broader patient groups.
Limited Patient DataThe program has treated only a small number of patients, which limits the strength of conclusions about safety and effectiveness until larger datasets are collected.
Safety And Efficacy UncertaintySparse patient exposure reduces statistical confidence in observed responses, raising the risk that early signals may not translate to consistent benefits in larger cohorts.