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Thoughts on PIONEER-6 Results
On Friday, Novo Nordisk announced positive top-line results from the oral semaglutide CVOT, PIONEER-6. Although PIONEER-6 did not meet superiority for 3P-MACE, Novo reported statistically significant (ss) ~50% RRRs for CV death and all-cause mortality. Below, FENIX discusses the likelihood for the semaglutide franchise to receive a CV risk reduction indication in the context of the somewhat divergent PIONEER-6 results, a description of different filing scenarios against Lilly characterized as high likelihood, low likelihood, and “power move”, what an FDA adcom could look like, and finally, external factors of influence. PIONEER-6 consistency check Below is a table comparing the results……

