Thats not what I said... you measure patient day one, they go through treatment, and get measured again later. And get results.
Patient one is a healthy 39 yo AML patient. Does everything correctly.
Patient two is a 65 yo smoker, BMI of 42,T2D, and has mBC.
I believe patient twos lifestyle could have an impact on the outcomes of their own before and after measurement.
This is wherein lies my question.
I will fill you in once I get clarification from Michelle.
I also wasnt saying they should ask for accelerated approval. Was just simply wondering if this design would even be considered acceptable for the data package required for approval, or if it just gathers data to sell off to BP, and they then worry about regulatory pathway. Have they seeked any official guidance here? (Lets not forget RAC has terrible historywhen it comes to runninga clinical trial)... It sounds like a great design, and personally cant see ph1a/b not being successful, then off that I cant see ph2 not being tweaked to be more specific (why wouldn't they). However, that doesn't mean the design is suitable for approval requirements.
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