Saturday, July 21, 2018 8:13:21 AM
Ultraz2,
No. The option is and always has been adjudication of the PFS trial endpoint. I did not see flipper44's earlier post to sentiment_stocks, Lykiri and me about why pseudoprogression must be treated like non progression until progression is fully established despite trial parameters that might define pseudoprogression as an actual event. That "event" would then get reversed with adjudication at the end of the trial but not before. Adjudication is what Dr. Linda Liau would not be discussing in her video. She would only be discussing evidence based on trial parameters. Evidence based on trial parameters only in this Phase 3 trial might suggest a lack of separation between treatment and SOC only in PFS or in OS until the long tail begins to show itself more clearly at 36 months. She suggested this in her hypothetical scenario in which statistical significance is not found in the endpoints which is the worst case scenario where FDA might not grant approval based only on a long tail of 20%-30% longer term survival in some subgroup. The suggestion of this worst case scenario is in no way implying that this is the only way FDA would respond to this situation. Best wishes.
No. The option is and always has been adjudication of the PFS trial endpoint. I did not see flipper44's earlier post to sentiment_stocks, Lykiri and me about why pseudoprogression must be treated like non progression until progression is fully established despite trial parameters that might define pseudoprogression as an actual event. That "event" would then get reversed with adjudication at the end of the trial but not before. Adjudication is what Dr. Linda Liau would not be discussing in her video. She would only be discussing evidence based on trial parameters. Evidence based on trial parameters only in this Phase 3 trial might suggest a lack of separation between treatment and SOC only in PFS or in OS until the long tail begins to show itself more clearly at 36 months. She suggested this in her hypothetical scenario in which statistical significance is not found in the endpoints which is the worst case scenario where FDA might not grant approval based only on a long tail of 20%-30% longer term survival in some subgroup. The suggestion of this worst case scenario is in no way implying that this is the only way FDA would respond to this situation. Best wishes.
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