AVII77,
Just to be clear, though by your example I think you understand, your concern about a DSMB decision being cloaked by regulator action is not consistent with the qualifier "earliest appropriate time" in my statement. The reason I say this is your example shows a graph where all evidence for the period of time considered before a recommendation occurred pointed to positive trending. At no point was there an data inflection point below initial or overall trend. The red dots are suppositions. Even these suppositions demonstrate a closing trend toward longer term neutrality or benefit. The DSMB does not base decisions simply on suppositions but actual data points. Regulators base their decisions on all available evidence and that, in my mind, would include evidence from other trials which you have not specifically accounted for. By all accounts there should have been more pseudos in this trial than those accounted for by those placed in known separate groups. Please explain. Best wishes.
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