Sunday, June 28, 2020 4:32:21 PM
We received an update about the number enrolled at the time of the halt and the number given was "about 300". I assumed that was 299-300 with absolute confirmation potentially still needed for some reason. I know you said you have reason to believe that 1 or 2 additional SOC/placebo may have enrolled after the screening halt and that may also account for the "about" wording. However, if "about 300" were enrolled at 2:1 at the time of the halt then having 97-99 enrolled SOC/placebo at that time is very possible with 1 or 2 in process that could not be stopped without risking more open disclosure of the reason for the halt. Anyway, just some further thought processing going on and not questioning or commenting on your line of reasoning with meirluc.
One of a few questions I do have for you is how many living non progressed German SOC/placebo patients do you suppose there were at the time of the halt and might they fit into those 12 censors in question. Also, how might you maintain the blind by playing with the numbers if a stealth ethical intervention and crossover of non progressed German SOC/placebo patients took place? Might "about 90%" become 86.4% then back to 90%? Could that slide that flipper44 likes to point to from 2016 indicating that all placebo patients might have evented by then have resulted from an intervention? I don't know but there seems to be some wiggle room there that might have needed to be sorted out at the end of the trial and NWBO was definitely waiting out something important. Best wishes.
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