Historical reconstructions of what the record showed

Each rebuild shows what the public record held between the first movement in the evidence and the formal decision. Cut off at its evidence date, each case shows what was knowable before the decision, not what it looks like after the fact.

Metabolic Record moved past the claim

At the cutoff the public record no longer matched the claim as written, and the body that decides had a reason to act on it.

Semaglutide: from high-risk comorbidity settings to general obesity weight management

GLP-1 receptor agonist · Type 2 Diabetes / Obesity · Indication scope

The indication has widened from the high-risk diabetic and cardiovascular populations the pivotal trials studied to general weight management. The evidence that carried the first claim does not carry the second in the same way, and a payer or guideline body deciding on the wider population will ask about the gap.

Source timeline
  • 2017-12 Initial FDA approval for type 2 diabetes
  • 2021-06 FDA approval for chronic weight management in adults with obesity or overweight with at least one weight-related comorbidity
  • 2023-11 SELECT trial cardiovascular outcomes published
  • 2024-03 FDA adds reduction of major adverse cardiovascular events in adults with cardiovascular disease and overweight or obesity to the label
  • 2025-04 CMS declines to finalize Part D coverage of anti-obesity medications for weight management
  • Nonsteroidal MRA in diabetic kidney disease: a guideline recommendation strengthened Cardiorenal · CKD associated with Type 2 Diabetes
  • Anti-CD3 antibody in type 1 diabetes: the record before the regulator acted Metabolic · Type 1 Diabetes
  • Amyloid-directed therapy in early Alzheimer's: the coverage restriction and the evidence since Neurodegenerative · Early Alzheimer's Disease
  • Anti-amyloid antibody in Alzheimer's: the efficacy question as the public record states it Neurodegenerative · Alzheimer's Disease
  • These are historical reconstructions from public sources, labeled separately from the registered forecasts.
  • Later outcomes cannot enter the evidence state at the declared cutoff.

Oncology decision timing

Read a subject dossier connecting the observed evidence, registered guideline and label questions, and the consequences of earlier or later action for each team.

First-line oncology decision dossier