Final analysis in APS
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If our TMA includes our 2nd interim analysis (median duration of follow-up was 18 months) and our final analysis is now published (median follow-up was 40 months at study end), can all data points from the final analysis be included in the APS?
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There may be opportunity to include the final analysis providing it meets all the requirements set forth in our Guidance Regarding Duration of Clinical Trials Used as Reference Support in Advertising. As we do not have the actual TMA and published paper for review, we are unable to provide a definitive answer. We suggest submitting an opinion if you remain unclear after consulting the guidance document.
