Replies to post #652125 on NorthWest Biotherapeutics Inc (NWBO)

[alphapuppy]

If you read the book for blood and money, which was a very good review of some of the targeted agents. Some of their scientific advisory board members were able to do one of these applications in like less than a month, all by themselves, without any publisher or anything. Then again, they had very good compelling data.

[learningcurve2020]

And, do you think that's material?

[Rh2022]

lol.

[alphapuppy]

It has been over three years since the data was locked. That’s gotta tell you something. Three years is a purposeful thing. Unbelievable in the length of time after data lock. And all the while patients are suffering.

[ae kusterer]

alphapuppy: With confirmatory data, the enterprise value for the combo partnership can be set much higher.What's the value of a 50% chance of living 7-10 years , given a GBM diagnosis?

Re: alphapuppy post# 652123

Thursday, November 30, 2023 6:11:09 PM

Post#
652125
of 652138
I think the delays may have been purposeful, because I think management may believe that the regulators will request a confirmatory trial, and NWBO wants to be able to say OK here you go. Here’s some combo data as a confirmation. And we’re getting close to having the combo data read out.

There is now an update to the preliminary results for the $NWBO UCLA DCVax-L + Poly-ICLC Combo trial.

In Oct 2022 the slide deck was updated for Dr Liau's presentation. The KM Curve now shows a ~50% Overall Survival now approaching 10 YEARS. Pretty phenomenal stuff! pic.twitter.com/bNIx81pZGm

— Tommy Bax 🇬🇧 🇹🇼 (@TommyBaxendale) April 26, 2023

[skitahoe]

I certainly believe that Oncologists worth their salt will use Poly-ICLC and/or Keytruda, and perhaps other therapeutics off label in treating patients, however, I doubt the regulators will consider the trials run to date at UCLA are deemed to be sufficient to utilize for labeling considerations on these products, and likewise for acceptance of DCVax-L itself.

Don't get me wrong, I believe the regulators will encourage the expansion of Phase 2 Trials to gain this acceptance, not require Phase 3, but I think they'll want the total numbers to go higher, and more institutions to be added to where the trial is being run.

What I'm really eager to see is trials in additional cancers, and of course the initiation of DCVax-Direct back into the clinic. Our potential is so much greater than what's been confirmed to date. If the company is right about tumor agnostic, once that's recognized, if NWBO isn't bought out, it will be among the giants rather quickly.

Gary

[meirluc]

I would like to know alphapuppy, why the the phase 3 results as
presented in JAMA and elsewhere are not good enough for an
approval request from the regulators and are instead in need of
conformation from combo trial results?

If that were true and the trial results were borderline good or displayed
some serious deficiencies in terms of some suspicion of cherry picking in
selection of patients, I would go along with the suggestion of running a
confirmatory trial or waiting for the results of an existing combo trial.

However, in this trial, there was no statistically significant differences between
the mOS of the trial's unmethylated GBM treatment patients and the mOS of the
ECAs counterpart (therefore no cherry picking happened here), while the mOS
of the trial's methylated GBM treatment patients was about 9 months longer than
the mOS of the methylated GBM patients of the ECAs. Rather impressive.

Also, although the group that ended up with 92 placebos included 29 permanent
placebos who per Dr. Liau had a dismal mOS, the mOS of the entire trial of 331
patients (including 232 treatment patients) had an mOS which was 0.8 months
longer than the mOS of the group of 232 treatment patients. That means that
despite including 29 permanent placebos whose average mOS was short, with
only 64 crossover patients, the mOS of the entire trial of 331 patients was increased
from 19.3 to the 20.1 months mOS of the entire trial (331 patients).

We can assume that when taken together, the combined mOS of the 232 treatment
patients and 29 permanent placebos (261 patients) would have ended up somewhat
below the 19.3 months post randomization of the 232 treatment patients. That those 64
crossovers were able to lift the mOS of 261 patients from below 19.3 months to
20.1 months, suggests that the mOS of the 64 crossovers could have exceeded
24 months. That would be a very impressive mOS for those crossover patients.


Of course we do not know whether those 64 crossovers benefited from a greater
proportion of methylated GBM patients than were present in the rest of the trial
but if that was not the case, the impressively long mOS of those 64 should also
be taken in consideration by the regulators.

[Maverick0408]

You will not get a response to this. In all likelihood, the management decided to wait for ph 2 combo data a long time ago and intentionally withheld this material info from shareholders. This is why I believe they could potentially get in legal trouble in the coming months.

The story around delays with publisher and contractor is BS. It’s just a smoke screen!