Know the questions a skeptical FDA reviewer will probe — before you're in the room.
Clinical research has a recurring failure mode that statistics alone can’t explain. A trial meets its prespecified criteria. The analysis is technically sound. The uncertainty is quantified. And yet the regulator says no, or asks for more data, or limits the indication, or quietly signals discomfort that never quite
The Bayesian vs. frequentist debate usually centers on philosophy. Priors are subjective! No, they formalize existing knowledge! You're smuggling in assumptions! You're ignoring relevant information! It's a fun argument. It's also the wrong one, at least for regulatory decision-making. The real value
Between late 2024 and late 2025, FDA approved six rare-disease therapies supported primarily by single-arm trials. None of these sponsors ran randomized controlled trials. All received traditional or accelerated approval. What separated success from rejection wasn’t luck or regulatory leniency. It was understanding what evidence compensates for the absence
