Tuesday, February 05, 2019 5:14:06 PM
For GBM, using OS is the standard. The fact that this trial has 3 years of survival data on every patient it would serve the trial well to have a co-primary endpoint. That the board discussed a while ago and unanimously agreed. Maybe they read this board and considered it, but just so at a junction near the end of the trial. If they haven’t done any analysis then it’s just a matter of wait time trying to get it through. The time it takes to go to all sites to verify PFS data and close out clinical sites may end up lining up well to get the 4 regulatory bodies to approve an updated SAP. I don’t see it as an issue. It makes sense to me that they pursue changing the SAP simultaneous as they close out sites. In my view it’s a smart strategy to update since they have at least 3 years of survival data on every last patient.
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