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Regulatory Science

09
Apr
6 min read

When FDA Says Yes and NICE Says Not Yet: The Same Trial, Two Different Questions

In July 2023, the FDA granted full approval to lecanemab (Leqembi) for early Alzheimer's disease — the first therapy to demonstrate disease-modifying benefit at that level of evidence. Fourteen months later, the National Institute for Health and Care Excellence (NICE) declined to recommend it for the NHS. A third

02
Apr
8 min read

What Everyone Else Submitted to FDA on the Bayesian Guidance

The disagreements in the comment docket tell you where Bayesian regulatory science still hasn't settled.

31
Mar
6 min read

The Grammar No One Reads: How Platform Trials Standardize Statistical Design

If you look at a single ComboMATCH substudy on ClinicalTrials.gov, you see a clinical trial. Two-stage design, 30 patients, objective response rate. It looks like any Phase II study. If you look across substudies, you see something different. You see a system. I was a statistician on two SWOG