Clinical Trial Size And InterpretabilitySmall proof-of-concept studies limit interpretability and create uncertainty about how observed signals will translate into larger trials.
Early-stage Development UncertaintyEarly-stage clinical data leave considerable uncertainty about durability of effects and safety across broader patient populations.
Program And Corporate RisksClinical, regulatory, financing, and commercial risks could delay development or constrain advancement of PALI-2108 into later-stage trials and commercialization.