Thanks Walldiver for your wisdom. I have a question regarding the interim analysis, which I posed on the Biotech board.
If Fleming's letter is what broke the camel's back- basically study 9902b will be seriously impaired by cross-over, and given that FDA is clearly in favor of approving based on current efficacy package, wouldn't it be helpful for DNDN to negotiate an interim analysis (with penalty on alpha) at an earliest opportunity when all placebo patients have developed pain by the time the class 2 resubmission review is done?
If it is statistically significant, although low likelihood but not much lower than the 180-event analysis then approval early.
If not significant but trending positive, approving then would have had additional data support, and taking care of the study conduct concern.