Replies to post #792002 on NorthWest Biotherapeutics Inc (NWBO)

[RRP60]

I saw the board stayed very active on today also. Between the ongoing delay in decision and the realistic financial possibilities discussed  by some decent longs here,  made me to think in many ways about this investment. Then the frustration from some of my brotherly longs and insane negative noise from the anonymous non invested skeptics made me slightly weak and make me to think of  am i  dreaming too much here and foolishly squandering big sums of my money like an idiot. Then, LC innocently suggested liau's last year podcast. I went back and listened to her again and i got my balance back. This is a science based investment. Kindly listen to ashkan, liau and bosch to understand about this technology. The skeptics who put holes to this science are nameless good for nothing keyboard warriors. Falling for their negative reasoning is the most idiotic thing i or ohers can do in taking a decision. Nine out of ten times these bad actors can be right, but that comes from their ability to annihilate these struggling companies with their bad actions. However, the technology here is a game changer in my opinion, unless all these reputed researchers are pulling a theranos on us and they certainly are not.  The longs who has faith need to give it a chance to play it out. We may get our much needed 5-10 dollar value for starters quickly after the approval. LP is smart enough to make it happen after the approval. Many new possibilities can happen after the approval and one or many of them can help the price appreciation. Have faith in this technology and LP, we may see decent gains in our investment if we get approval. Keep in mind this is not my palantir investment which quickly went from my 28 cost basis to current valuation of 170 or 180. Our nwbo can also do that,  if it moves in the right direction from here on. Every dose this company will make after approval will bring hope in some patient's life.  Profit and loss should not be seen in saving a human life. I just shared my thoughts after reading today's discussions.  🙏🏾

[theorysuit]

Everyone including LL knows it needs a new trial for approval. Even LP knows it. But nah that's just FUD. 661 DAYS AND COUNTING.TELLS YOU ALL YOU NEED TO KNOW...........

[Smitty5150]

you are flat-out lying in your "interpretations" of what Dr. LL actually said during the interview. She never stated any of what you claim. I would advise everyone to listen to the podcast for themselves. She states she hopes other trials will use ECAs in future. She also states at the end, she hopes, based off the efficacy of DCVax, it will approved by the US FDA. Also, she states she hopes some of the new trials with combo therapy, could be incorporated in the SOC for GBM in the future. This proves you are twisting words, and in most cases flat-out lying, to fit your narrative.

[sentiment_stocks]

It’s interesting, LearningCurve, how your interpretation of that May 2024 interview is so much different than mine. Perhaps you’re just hearing what you want to hear, and maybe the same can be said of me. But I do think that having the entire audio (and transcript) available can allow others to come to their own interpretations.

The entire transcript is available on this post.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=176811056

So considering your post from the other day...

Here on this YouTube audio from 2024 @ 32 minutes in Dr. Liau seems clear that DCVAX-L is not ready for commercialization. She just hopes that it can be placed in the Right to Try category to compile real word data for proof of efficacy. “Next steps are studying MOA and enhancing the efficacy. She says Seems to be a signal of efficacy. She hopes some day it could be FDA approved and speaks of subsequent trials as further proof of efficacy. She foresees another randomized trial only with the right sponsor. Says nothing about commercialization with MHRA only Compassionate use in the UK. Says Needs more validation of efficacy. More combo testing. Patients doing off label with less proof of efficacy so why not L? Speaks about Right to Try.

Nowhere in this audio presentation does LL claim DCVax is not ready for commercialization.

Yes, she does indicate that DCVax-L is (was - this was in May 2024) available for compassionate use in the UK, but one needs to read LL's complete comments to understand the context.

As for her statements regarding “subsequent trials as further proof of efficacy”, those were in answer to the interviewer’s question:

Dr. Neville: So on that note, do you foresee DCVax-L being in a combination randomized controlled trial study looking at DCVax-L with a different agent or another study with temozolomide and a randomized controlled trial setting?

LL’s fuller answer to the question paints a different picture than you presented. In fact, she notes some of the problems with randomized trials.

Dr. Liau: You know, one problem with a lot of randomized controlled trials is itself is also artificial compared to the real world use of a lot of our therapies. So whether I foresee another randomized controlled trial, I think it depends on the sponsor of the trial. But I think if we are able to get these options out to the community for testing, I’m hoping that there will be greater data that we can generate. ‘Cause I think one of the problems we have with a lot of these clinical trials of single agents is that without access to the agents, it’s hard for people to do these combination studies. So I’m hoping there will be innovation in the field in terms of how we can best move some treatments forward given the current regulators. As well as, you know, clinical trial environment that kind of limits how we do larger trials with combination therapies.

And, contrary to your claim that "Right to Try" is pretty much all that LL is hoping for... she instead indicates that her hope for DCVax-L is that it can be FDA approved someday. But of course, Northwest has to first submit an application.

Dr. Neville: So how do you foresee these results potentially impacting patient care in the future?

Dr. Liau: I think for next steps for DCVax-L, based on what we’ve learned about the mechanisms, (illegible), and the potential biomarkers of response, we are currently conducting additional studies to look at the combinations of DC vaccines with various immune checkpoint inhibitors and immune modulators so we can hope to further enhance the efficacy… because even though there does seems to be a signal of efficacy with an almost 20% five year survival rate, that still means 75 to 80% of people aren’t living five years. So I think we as a field need to do better. I think there’s not going to be a one magic bullet that cures glioblastoma, but having different options available to patients for real world studies of rationalized, personalized immunotherapy, I think, would be useful for the field. So given the very favorable toxicity profile for DCVax and its potential efficacy, I do hope that it can be FDA approved some day, and incorporated into testing various combinations if not standard of care in the future if these subsequent trials pan out.

I should note that I believe by "subsequent trials" panning out, she is likely referring to the UCLA combo trials. And as I noted in a previous post to Less is More, LL indicates that DCVax-L is also only currently available in the U.S. in ongoing clinical trials, which most of us know are the UCLA trials that are using DCVax-L, despite what the naysayers indicate.

Dr. Liau: This was a Phase 3 non-randomized prospective cohort trial for an autologous vaccine for brain cancer that has shown some promising results. However, it is not yet FDA approved so it is not currently available in the U.S. outside of clinical trials, and further clinical trials are ONGOING using THIS agent.

So, IMO, LL's comment sorta kills the idea of those who are not long that UCLA is using a different version of autologous dendritic cell vaccine and not DCVax-L.

While LL notes a 20% five year survival rate in the trial, she is speaking to the MGMT methylated patient population in the trial, which she had noted earlier in the interview (shown below).

LL: But what I think might be more interesting is the long tail end of the survival curve. And some of the subgroup analysis results that came out of the trial. For instance, the median survival of the MGMT methylated patients was over 30 months, with an almost 20% five year survival. What was interesting is that the majority of these patients surviving over five years are surviving without recurrence, which, in the field of glioblastoma, is actually quite unusual.

Interestingly, that five year 20% rate for the methylated patients was for survival at 24 and 30 months (20.7% vs. 9.6% in the control arm). And so in this audio interview, she's indicating that this survival rate has continued on out to at least 60 months.

From the JAMA article:

Survival was improved in patients with nGBM with methylated MGMT receiving DCVax-L compared with external control patients (HR, 0.74; 98% CI, 0.55-1.00; P?=?.03).

https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847

One of LL’s concerns centers around the availability of treatments for these clinical trials, and it’s her hope that DCVax will be approved so that it can be more easily tested with other agents to achieve even higher response rates… as transcribed here from the audio:

Dr. Liau: DCVax-L is currently available for compassionate use in the U.K. It was approved by the MHRA for that purpose. It’s not yet FDA approved. And I think in terms of access to treatments, there’s the balance between access and also getting more data and validation of efficacy. And I hope there will be a way in the future to be able to do both, you know, to be able to allow patients access to treatments, and then have the neuron-oncology community continue to test agents and come up with innovative trials to you know, prove or disprove efficacy. You know one problem is that unless you can get access to the agent, it’s very difficult to do that. So perhaps a way to open access to DCVax will continue testing would be beneficial to the field.

Anyhow, thanks for pointing out that YouTube presentation. You forgot to link it, but I was able to find it, so again, thanks.