Well, I do hope they now have a solid plan now as to what is going to go into the SAP.
I can't really see beyond two choices.
Either they stick with PFS, with the independently powered OS alongside or right behind.
Or they jettison PFS, and rely mainly on OS (backed up by no toxicity). That would presumably entail requesting a waiver,
because they would be departing completely from the long time primary endpoint. And would also require them defining what statistical tool or technique they are going to use, to measure crossover effect.
If they are conducting a blinded PFS adjudication, and are confident that the outcome of that is going to be favorable, then they could actually draft and even submit the SAP with PFS remaining upfront, before PFS adjudication is completed.
But there would probably be no going back, once they have done that..
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