This is a a hard question to answer as the normal rules don't really apply in the case of paediatric AML. The most likely outcome is a very limited Phase 1 where the dose is predicted well based on the historical data. This is how the most recent Phase 1 stage was done in the latest Sheba trial - the first dose tested was the dose that was taken to Phase 2.
This is a a hard question to answer as the normal rules don't...
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