Replies to post #292172 on NorthWest Biotherapeutics Inc (NWBO)

[meirluc]

Yes Lykiri, I agree with you completely up to and including your statement that at least 15 of 25 placebos of the last group of 108 were
dead and no more than 10 placebos were still alive at the time of interim analysis (March 2017).

My estimate of 8 placebos who are PFS beyond 36 months is a worse case scenario. If there were a maximum 8 such placebo patients, most of them may have originated from about 74 placebo patients who originated from the first 182 patients enrolled and who were no longer individually represented (censored) in the 2018 JTM publication.

Furthermore, it is hard for me to take literally the November 2018 SNO update when it implies that between March 2017 and about May? 2018, 12 of the 66 placebos (18.2%) who crossed over, progressed so late after their surgery. How many of the about 10 most recent placebos surviving at 3/17 had not yet crossed over and did so between 3/17 and let's say 5/18? How many of the approximately 74 surviving placebos who were at 3/17 on trial for more than 30 months, crossed over so late in the game? There may have been a few but it is hard to believe that a total of 12 placebos crossed over so late. I have always wondered whether there was such a massive late crossing over or perhaps a purposeful final approximation at the 2018 SNO update which gave us the 90% crossover figure.

[Doc logic]

Lykiri,

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.