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Saturday, February 20, 2016 10:17:53 AM
Linda Liau did talk about crossover being a problem for the trial, and spoke of the comparison between the experimental and the crossed-over controls being the measure of efficacy. And true that only OS would fit either of those descriptions. But is Linda Liau privy to such trial details at this point, or is she just assuming that OS is now the sole metric of interest? I realize she was the chief scientist for the early trial(s), but what is her current role?
So far you have not refuted the possibility that they could currently be looking at PFS for early full-approval if the old bar of 6 months improvement is currently shown, based on a look at data that they may not have requested by NWBO or their DMC.
The current level of enrollment, not recruitment, is sufficient for consideration of full early approval based on the original primary metric of PFS with the original threshold for approval of 6 months improvement.
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