Replies to post #93357 on NorthWest Biotherapeutics Inc (NWBO)

[longfellow95]

By 'evented' I mean disease progression (unequivocal!) or death.
All deaths.

I don't know for certain if LL's statement that, thus far, less than 75% of patients have had an event, is accurate.

If it is, then I'm sure you know what that means; primary endpoint met.

You appear to have convinced yourself that it must be an erroneous statement.

I prefer to keep an open mind.

I'm afraid that your suggestion that the 32 'pseudo-progressors' more properly described as 'apparent rapid progressors,' are included in the 331 has no basis. They were always part of the information arm, and there is nothing to suggest that that has changed.

[sentiment_stocks]

You wrote...

Here are my guesses (in order of likelihood):

-248 PFS events reached already, company awaiting 233 deaths; 299 randomized into main arm, 32 psPD into separate arm

-248 PFS events reached already, company awaiting 233 deaths; 331 rand into main arm, 32 in psPD arm.

-248 PFS events not yet reached, company awaiting it, 299 rand into main arm, 32 in psPD arm.

-248 events not yet reached, company awaiting it, 331 rand into main and 32 in psPD arm (I give this last one, which most longs think most likely, only a 5% chance of being factual).

I’m quite sure your first guess, and the one you think most likely, will be proven wrong.

Nowadays, you believe only 299 were randomized into the main arm. But of course, I disagree. There are 331. The 32 psPDs are in a separate arm. At least one can say your suppositions are constantly evolving here.

They said 331 patients were in the trial. They previously had made it clear that those 32 psPD were separate from the 348 main arm group. And you know there is a 3 month screening for this trial and that the vaccine was made for all patients in the beginning of that screening process. They wouldnt want to exclude those patients for which the vaccine was made. The screening halt applied to any new patients for whom the vaccine had not been made. The company made it clear that in August 2015, 300 patients were enrolled in the main arm of the trial and that excluded both rapid and psPD patients. It makes no sense that they would suddenly include both arms in the one count.

And over the months since August 2015, you, yourself argued that the number of patients in that screening arm would never amount to 48, but that there might be 10 or 15 or so, if memory serves me. So now we know there were instead 31 patients that made it through screening into the main arm. You’ve argued pretty intensely in the past that the two arms were quite separate, and so to suddenly make this your primary supposition seems rather disingenuous to me.

As for the 248 events having already occurred, I’d argue the 248th event still may be what we are waiting for. I’d have to argue that the company’s current silence indicates otherwise. On top of that, LL’s own video presentation argues differently.

It could very well be that — being PFS is the primary endpoint — if it hasn’t been reached, waiting for it easily allows the company to hold out for those OS long tail events… which is what LL is quite focused on in her most recent presentation.

And supposing there were treatment patients exhibiting false events too early, there would still be a majority of treatment patients that would not exhibit false progression based on the vaccine. After all, most treatment patients should not exhibit this false progression… although there may have been enough of it to wreak some havoc with this trial. And if 83 treatment patients have not even evented by this time, it argues that it's the treatment arm that's ultimately holding up the trial from reaching that 248th event.

And of course, I'm of the mindset that AT LEAST 83 patients have not even evented… based, of course, on LL’s slide which shows no blue bar indicating there are no placebo patients that have had no progression nor recurrence.

Here are those figures again...
331 - 110 placebo patients = 220 treatment patients.
248 events - 110 placebo events = 138 treatment events.
221 total treatment patients - 138 treatment events = AT LEAST 83 patients without an event.

And to further advance the argument that 83 treatment patients have not even evented…

LL herself stated what we are comparing are those patients that all have received DCVax-L - either in the beginning or after they evented.

If there were some number of placebo patients that had not evented yet, wouldn’t they figure in on the comparison as well?

We all know LL put out a slide showing there are no placebo patients that have not evented as a percentage of the trial population. Here’s the actual transcription of that section. Please notice how LL does not even reference the placebo group that didn't event and didn’t cross over. She rolls right over that entire placebo section except to state that there ARE some patients that “got progression” and “got the DCVax at recurrence.” Please notice the tenses. When she speaks about recurrence, she speaks in past tense. When she talks about the green boxes, she speaks in past tense.

38:37
So here’s um, so here’s the treatment groups, again… we’re still blinded to the results… but what we do know is that two thirds were uh randomized to DCVax and a third to placebo. So all the boxes in green got DCVax at some point. So obviously the top part of this chart, those were the patients, um, who randomized to the treatment. And at this point, and looking at their analysis, they either had no progression, they either had progression and recurrence and went on some other treatment, or they had progression and recurrence and then just went on standard treatment and continued with their vaccine. Um, the placebo arm, uh, there WAS a percentage of those patients… like I said, because of the cross over arm, that GOT progression, um, that GOT the DCVax at recurrence. And it turns out that the green boxes ACCOUNTED for 86% of the patients. So a significant percentage of these patients actually did GET DCVax at some point.

If there were some placebo patients that haven’t evented yet, I'd argue then that she couldn’t very well state that there were 86% that received DCVax and 14% that didn’t… because some percentage of those 14% would still be in line to add to that 86%… upon getting progression in the future. So I’d argue, she’s being very unequivocal in her presentation here.

I believe you are arguing against the facts that are out there in both cases. To be fair, there could be new statements and charts that come to light that change the facts that are presented thus far. But I'm stating that to accept your current premises, one has to accept that the company suddenly decided to meld the two groups they've thus far made a point to group separately (main arm and psPD arm); and additionally, that the chart LL featured in her presentation is incorrect, and that in her presentation where she speaks of all patients events in the past tense, and makes no mention of any placebo patients that have not evented, and that she also made a mistake in not clarifying that there were placebo patients that hadn't.