Replies to post #373956 on NorthWest Biotherapeutics Inc (NWBO)

[anders2211]

and when the comparison between the arms fails tries to get approved based on post hoc endpoints against historical comps.

objection speculation you dont know it failed! you are saying that but you dont have any prove it did

and again so the EMA/UK is nuts accepting new endpoints?


I have never understood your reproach of NWBO not continuing patients in the control arm so the stats can be better compared alas they must die in doing so.

[Dr Bala]

If the post suggests that the comparison between the arms failed, then it is a fabrication. Imo, there are not enough patients in the control arm because of crossover.

[iwasadiver]

First, it’s not “Post Hoc” and saying that is incredible misinformation. You can’t simply say things like that so matter of factly, it’s irresponsible. Of course the last 4 years have made this type of thing common place in the culture. Secondly, there are not enough people in the placebo arm to ever get enough power for OS so the separation is not a “failure” it’s a result of changing understanding of immune therapies and how they work. If you feel throwing the baby out with the bath water is such fundamental and unchangeable dogma then you’re nothing more than one of the many staunch regressive thinkers over the centuries who choose to refuse acknowledgment of transitional science; the same people who persecuted Socrates, Jesus, Rhazes, Servetus, Galileo, and Einstein to name a few. Many fight to the end for such dogma as to make their efforts in retrospect appear illogical, defensive, and mean spirited at best.

[photonic5]

I think the biggest issue lies in statistical significance with regards to the trial control data. 30 true placebo patients just may not be enough to determine statistical significance in this trial. What the historical control should do is allow for statistical significance.

I can see that being the argument of fudsters, but it would have just been unethical to enroll further placebo patients just to get to statistical significance. That was Dr. Liau’s point all along.

[biosectinvestor]

No, they have added more freedom and more guidance Justin recent years, so of course you have not seen THIS before, as the change was made due to immunotherapy trials with these very issues in mind, most likely this one in mind, and specifically, though, because of the reforms made possible by the 20th Century Cures Act, which was at last allowed to be passed at the end of the Obama Presidency in lame duck session after being held by certain opposition prior thereto, for years.

Therefore that law was not in operation a decade or decades ago and of course this is new, the law is only being implemented into guidance and regulations gradually, though rapidly for the FDA.

[X Master]

If Biden weighs in, it will be a done deal.
On another note, while I believe this trial will have moved the needle on the overall knowledge of GBM, it seems like we still have a lot to learn. So I hear that we are “matching” control and placebo patients, but are we really? We simply need to move the needle and go with the overall success rate. No trial reaches 20% blinded.

[hope4patients]

What other GBM trial in the history of mankind shows approximately 20-25% of patients living 5yrs? Patients will demand this treatment and your FUD will no longer matter.