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RWE Presentation

Scheduled Pinned Locked Moved PAAB Q&A
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  • L Offline
    L Offline
    Lora_Nolan
    wrote on last edited by
    #1

    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)?

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    • Jennifer CarrollJ Offline
      Jennifer CarrollJ Offline
      Jennifer Carroll
      wrote on last edited by
      #2

      Hello @lora_nolan

      This is a review question. Per the Community Guidelines (see top right corner), this does not meet the use conditions for the Forum. Please address review questions through the appropriate channels by submitting a ticket for a call with the Reviewer through eFiles.

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