Again cancer indications where the risk vs. clinical benefits equation is quite different from AD and biomarkers are quite dependable surrogate endpoints.
Thanks, Steady. I found an earlier NIH paper that states "the FDA usually requires more than one phase III trial to establish drug safety and efficacy" but didn't provide that level of detail or current information.
For the drugs that got approved with >1 pivotal trial, I wonder if some of those were conditionally approved after a single Ph3 trial with the condition that a confirmatory Ph4 trial be run?