JJ/VuBru/flipper et al., a challenge question for all of us: please forgive me that I am in no way trying to offend you. I am just trying to understand the seriousness of the situation. We all know that it is a fact that 90% of the placebo patients crossed over. So you experts educate us, with the 10% remaining, even if all those 10% progressed and were dead so long ago, but still will the treatment arm fetch a statistically significant (SS) efficacy just comparing against that 10%?? If it could not be possible at all, then is it fair to ask NWBO to produce an acceptable paper on that ground in that endpoint? Is it fair for FDA to expect to make it happen that if it is statistically impossible? Is it fair to conclude the trial failed in that case in those endpoint(s)? Is there a trial expert or statistician out there who could still prove SS with that just 10% placebo patients at what extreme? I don't think so unless they compare the dominant subgroup in that 10% placebos to that in the treatment arm. By the way thanks flipper, I can do the math/statistics that we sure are going to get rGBM label. Thanks in advance guys for your response.
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