Replies to post #584242 on NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

Lykiri,

In my opinion those censors go a long way in explaining a potential stealth crossover and Fraunhofer’s comment that the trial was enrolled to the point statistically necessary. Might also explain some of the flattened curve with methylated from 24-36 months if crossed over to treatment before progression. This is why I state the opinion that regulators essentially green lighted this in 2015 but NWBO did not have commercial scale manufacturing ready due to finances, wanted to strengthen the powering with time and perhaps a different rollout plan than originally contemplated. Guidance also needed to be changed to educate and ensure minimal resistance to safe passage. Best wishes.

[meirluc]

Thank you Lykiri for the information you provided which yields much food for thought.

Interesting that out of 99 placebos, 30-31 were alive at 32.9 months from randomization and 20 of them were MGMT methylated placebos. That would mean that almost 50% of those 41 methylated GBM patients in the group of 99 placebos were post 32.9 months survivors and my uneducated guess is that well over 50% of the methylated crossover patients are in that long living group.

You also pointed out that most of the 18 placebos whose progression was never confirmed were censored after 12 months. I am also wondering how many of those censored placebos, not only survived past 32.9 months but may have survived past 5 years? The 2018 SNO statisticians predicted that 50 patients were going to survive at least 58.4 months from surgery (55.3 months from randomization) which suggests to me that perhaps at least 45 would have survived 60 months from randomization. As I understand it, there were 25 post 5 year treatment patients with beating hearts although
the 13% post 5 year survival figure implicated 30 such patients. However, both of those survival stats would likely still fall far short of the 2018 SNO estimated long term survival figures.

Question: When all the crossover survival figures are revealed, will a few more 5 year survivors ascend from the 18 censored (unconfirmed progression) cases?