We submitted for an opinion regarding overall survival data and this was the response "As the "OS data remained immature" per the Cambridge 2021 paper and analyses were "posthoc/exploratory" in nature, claims based on OS data (Claim #4) are not considered (s3.1.1)." Would it be acceptable with the RWE presentation (attention icon, disclaimers, grey box, etc)?
L
Lora_Nolan
@Lora_Nolan
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Posts
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RWE Presentation -
Duration of Clinical Trials Guidance for New ProductDoes the "Guidance Regarding Duration of Clinical Trials Used as Reference Support in Advertising" also apply to new launch products once NOC is granted by Health Canada? I understand that there is a pre-NOC submission pilot. My question is pertaining to including claims from the pivotal trial(s) that are not included in the PM of a new launch brand.
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Final analysis in APSIf 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?