Mechanism And Biomarker UncertaintyAnalyst raises concern that the mechanism driving durability is not confirmed by human biomarkers, leaving uncertainty whether human pharmacology will reproduce the pronounced dose-response seen in animals.
Monotherapy Efficacy SetbackAnalyst expresses disappointment in minimal monotherapy activity, noting that weak standalone efficacy could constrain development pathways if combination advantages fail to generalize.
Trial Design And Sample Size LimitationsAnalyst flags small sample sizes, potential selection bias, and loss of randomization across study portions, which complicate comparisons and necessitate larger, controlled trials to validate results.