<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.
David Miller (subs reqd) has a lengthy report / speculation out today on what enabled Pazdur to trash Provenge. If it's right, the chances of such circs repeating next time around might be slim, so greater FDA flexibility about data purity might be a fair assumption.
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