<This would be done in case the alpha allocated for the interim look is in the 0.01-0.015 range, but 9902B's interim p value comes back between 0.015 and 0.05. The FDA would have to bend its Pazdurian standards somewhat to grant approval in this example>
Agree. I said earlier on iVillage that this might be a good reason for DNDN to tread lightly around the FDA despite recent events. ENCY did not manage their relationship with the FDA well.
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