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More Thoughts on PIONEER-4 and Potential Novo Regulatory Strategy for Oral Semaglutide

Here is a brief preview of this blast: For the four Ph3a oral semaglutide trial data disclosures thus far, Novo has consistently discussed two statistical analyses performed: on-treatment and intention-to-treat. FENIX believes this directly plays into Novo’s oral semaglutide regulatory strategy including preparing for an FDA adcom, the submission dossier, and proposed product label. Below, FENIX discusses more thoughts in the context of the PIONEER-1 study and potential label implications from Novo’s statistical representations that could allow for PIONEER-4 superiority vs. Victoza in the label.