What Is IMU Really Worth?, page-110

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    Yes. Particularly if there is human evidence suggesting elevated endogenous IL-2 levels correlated with efficacy.

    I think your hypothetical scenario is reasonable, though you would more likely be evaluating the entire dataset. You are correct that it has to be proven. This process is not uncommon to science or biotechnology.

    One of the clearest examples of circumstantial evidence in drug development is Ozempic. It was originally tested for type 2 diabetes, but during those trials, it also showed a strong ability to reduce body fat mass. That observation wasn’t the primary goal of the studies, but it suggested a promising new use. While this effect still needed to be formally tested in dedicated weight-loss trials, the risk that Ozempic wouldn’t reduce body weight was low - because the effect had already been seen consistently across a large number of patients.
 
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