Forum Update: Supporting Community-Led Discussion
The forum was created as a space for shared learning and peer support, and as the community grows, we want to lean more fully into that purpose.
Going forward, PAAB will be taking a more listening-first role in forum discussions. Rather than responding immediately to every question, we’ll be encouraging members to engage with one another, share experiences, and help build collective understanding. PAAB will continue to monitor conversations and will step in to:
- Correct any misunderstandings
- Provide guidance when questions remain unanswered after a few days
- Support discussions where official clarification is needed
Our goal is to foster a collaborative, trusted community where knowledge is shared and strengthened by everyone’s contributions.
Thank you for being part of the conversation.
RWE Presentation
-
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)?
-
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.