Clinical, Regulatory And Financing RiskClinical, regulatory, and financing uncertainties remain significant and could delay development or commercialization even if early signals appear promising.
Data Robustness And Trial DesignSmall, open-label datasets limit confidence in results and raise the risk that observed benefits may not reproduce in larger, placebo-controlled trials.
Microbiome-dependent Activation RiskDependence on bacterial activation in the lower gut means inflammation or microbiome changes could alter drug activation and exposure, creating unpredictable efficacy and tolerability.