Those results will be compared to HISTORICAL by a BP (they are not bound to apply the FDA rules) because BP will NOT want to take the risk that a result is GOOD because the CONTROL ARM UNDERPERFORMED. They know the drug has it value if it improves on the historical max. of 10 months and that it is WORTHLESS if it would have beaten a poor 7 months control arm by setting down 10 months.
Great point! investors should read and understand your logic.
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