Replies to post #583898 on NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

While we'll never see it, I suspect that in the roughly a million pages the regulators get in applying for approval every participant in the trial will be fully documented. I suspect that they'll see that all that didn't cross over had either evented by the time they could, or were so sick that they chose not to, and they evented shortly thereafter. I doubt if we'll ever see the data that truly defines that as happening, but the regulators will. A K-M plot for all those who never crossed over would say if this was the case, perhaps at some point that will be produced.

To me, 99% of the million pages could be eliminated and there would still be enough meaningful information to approve the vaccine, but the regulators insist on doing things as they always have whether the pages are actually printed, killing all those trees, or handled electronically. I'm guessing that it's rather like many Congressional bills, no one person reads every page, and I'd suspect that some pages are completely unread, but if they're not included the filing isn't considered complete.

Gary

[hoffmann6383]

Dr. Liau also said 29 in that Musella presentation if I remember right

[meirluc]

Thank you Lykiri for your info. Here are some of my thoughts.

1. I mentioned that there were 29 permanent placebos at the end of the trial because some time ago in I believe Al Muzella's Q and A Webinar segment, Dr. LL stated that 7 of those 35 dropped out before the end of the trial. However, if I understood you correctly, except for one drop out, 5 of those placebos were among the 81 with documented progression and that would add up to at least 98 patients (92+5+1=98). That means that those patients were recorded as having progressed before they dropped out and if this is correct we have at least 98 of the 99 accounted for.

2. However, I am still uncertain about the following: You counted 81 progression events of which 48 occurred before 7.6 months on trial and 33 progression events thereafter which would add up to an mPFS below 7.6 months. Fortunately if there were only 81 recorded progression events in that group of 98-99 patients, there must have been 17-18 patients whose progression was never established. If let's say15-18 of those patients were judged as not having progressed during the trial and were added to the 33 who progressed after 7.6 months, then 48-51 such patients match the 48 patients that progressed before 7.6 months and that would approximately legitimize the mPFS of 7.6 months.

3. Finally, is it not likely that most of those 48 who progressed after 7.6 months were crossovers and that a large proportion of the earlier progressors were permanent placebos?

[meirluc]

The 7.6 months mPFS of the 99 placebos completely destroys the naysayers argument that cherry picking was used to select the patients in the DCVax-L trial. A placebo patients' mPFS of 7.6 months, extrapolated to the 232 treatment patients would not predict that those treatment patients would have an mOS of over 19 months

Have not some of those criticizing the trial taken note of that? Were they not aware of the fact that the mOS of the 131 unmethylated treatment patients in the DCvsx-L trial was almost equal to the mOS of the matched unmethylated GBM patients of the ECAs?