Replies to post #176746 on NorthWest Biotherapeutics Inc (NWBO)

[survivor1x]

It's not data mining if overall survival was pre specified and at 36 mo a percentage of patients are alive compared to placebo.

Why are you so confident pfs failed?

At least you acknowledge the data is compelling. I will agree that I would rather just have OS or 3yr survival as primary with no crossover. But provenge bested frovenge, I would be consisted for dcvax to beat crossover.

[flipper44]

One point I agree with is that you can only run out this trial for so long. It is incomprehensible to me that the advisory board would not finally side with Dr. Ashkan's perspective once the current refresh is complete. Consider the 36 month chart. The living patients will be beyond the 36th month chart. At the end of August, there will be no one outside the tail, no living person's censor mark on the 36 month chart. In fact, you could argue with their definition of "extended survivors" equaling 30 months or better, the very last living enrolled patient is already two months into tail. The intent of showing us just 36 months seemed self evident to me. There is no trial of this kind, this old that has not provided either results or at least an IA recommendation. The researchers themselves stated there is no variation based upon year to year enrollment. Another reason the KM curve should be sufficient at the end of this refresh.

(Caveat: If Dr. Bosch was right about the 2% event rate per month starting back around March 2017 at 108 patients still alive, I think waiting until 36 months after surgery will increase the survival number at that 36 month milestone from near 25% to near 30% -- thus hinting at some very late variation in the trial population. (i.e. perhaps the last 30 patients were all enrolled onto DCVax-L.)

[biosectinvestor]

I don’t think it “failed”, while it is possible that pseudo progression in some instances was initially mistaken for progression, I think you’re assuming you know more than you know. That has been a major issue with all the prognosticators, while guesstimating can ballpark it, it’s still often not able to get at the key details, and in a trial this advanced, and cutting edge, you just can’t know, in reality.

You can suggest as strongly as you want otherwise, but I’ll wait for the final analysis.

[Virgilio]

Apple and oranges. I am not talking about timelines, I am talking about efficacy. But the fact that you are in disagreement with the authors' conclusion doesn't surprise me, they are scientists in the field, what are your credentials to disagree with them, with all due respect?

[ADVFN_doclee]

"There are lies, damn lies and statistics" (Benjmin Disraeli; popularised by Mark Twain)

I am not a statistician and I'm wondering whether some of you knowledgeable number crunchers on this board might have lost the plot in your arcane deliberations and are now simply arguing because your pride insists that you don't give in to the other person's argument.

The trial might turn out to have missed its first and second stated objectives, and this will become apparent when the trial is unblinded (the sooner the better). However, one thing cannot be denied and that is that an obviously larger than expected number of patients have lived far longer than originally expected, some with no signs either clinically or radiologically of the disease. It would be bordering on the insane or irrational to explain such an outcome by anything else except the addition of DCVax-L to the treatment regimen.

So, even if the first and second objectives are not met statistically are the statistical bears among you going to claim that the trial has failed? Whether you do or not will be an utterly futile waste of your time (unless your purpose is to sink NWBO as quickly as possible in which case you are unprincipled, money-grubbing low lifes of dubious parentage) and expose you to the righteous opprobium of the public because the drug will be approved for use, probably as part of the Standard of Care regimen. Unless NWBO is sunk financially by all your bearish statistical nit-picking over failure or not, we'll all go home happy (except AF and some of his more obvious acolytes on this board) that our investments have at last born fruit and patients will now have at least a fighting chance of a meaningful extension to their lives.

Think on it.

[longfellow95]

We now need to wait for those last 60 or so ticks to march across the bit fat tail. Two years?

80 plus is more accurate, imo.

These remaining ticks are very torpid now, and for another 60 to march across would take at least 10 years.