Replies to post #292124 on NorthWest Biotherapeutics Inc (NWBO)

[survivor1x]

Gotcha, your generous on the 8 of 33. As Flip says the early pseudos(were removed from the 331). But even being conservative you show a 2 to 1 percentage of treatment over placebo post 36.

[Lykiri]

meirluc,

I have a few questions?

Do you believe that the last 31-32 patients are all treatment patients?

If your answer is “Yes”, do you agree that there are about 25 placebo patients in the last group of 108 patients? (first 223 patients randomized 2:1 = 149 treatment and 74 placebo. 99-74 = 25)

Do you agree that the last group of placebo patients may have received better surgical treatment than the first 74 placebo patients? (ALA-5 in Europe …etc.!)

Do you agree that at least 60% of placebo patients in this trial are dead after 22 months?

If your answer is “Yes”, at least 15 out of 25 placebos of the last group of 108 are dead and no more than 10 placebo patients are still alive at the time of the interim analysis. That was mid-March 2017 = 22 months after surgery of the last placebo patient (around mid-May 2015.)

Next question:

Do you belong to the group of ihub members who are convinced that the number of cross-over placebo patients increased from 54 to 66 cross-over placebo patients between mid-March 2017 ( interim analysis) and end of May 2017 (Asco 2017)? (From 86.4% to 90% of the ITT group) That is an increase of 12 cross-over placebo patients.

If your answer is “Yes”, I assume that you can only conclude that all placebo patients censored between month 22 and month 36 on the OS curve were progression free at the time of the interim analysis(WOW!!) and all these placebo patients(increase of 12) got recurrence from their brain tumour between mid-March 2017 and the end of May 2017. (10 placebo patients censored between month 22 and month 30 and about 2 out of 7 patients censored between month 30 and month 36 on the OS curve March 2017). Unbelievable!!

Conclusion: Do you agree that none of the last 25 placebo patients (the best group=ALA-5 surgery...etc.) were progression free 36 months after surgery if the above is correct ?

Last question:

If none of the last 25 patients were progression free 36 months after surgery, why do you believe that 8 of the first 74 placebo patients were progression free 36 months after surgery?

NOTE: 86.4% of the ITT population received the experimental DC treatment at some point during the trial at the time of the interim analysis March 2017.( https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-018-1507-6)

I believe that number of 86.4% never changed after March 2017.

OS curve March 2017:
https://investorshub.advfn.com/uimage/uploads/2018/10/22/gddzjCombined_charts_no_notes_revised_-lykiri.jpg