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Clarification- trial was never initiated
I have directly confirmed this with DI. That is another sure way to verify.
I'm a buyer today. Increased position 10%. August is almost here
Appreciate the reply.
Thanks!
Is the article that was published today the one referenced in the 10K? - "Continued compassionate use (Specials) patients. We continued treating compassionate use cases of GBM patients. We believe these treatments are helpful for the patients, and these cases are also helping us prepare for real world circumstances that we are likely to encounter in potential commercialization and that are much more diverse than in clinical trials. For example, the compassionate use cases include patients who have continued to receive DCVax-L treatments over many years (including having a second batch of DCVax-L doses made after the first batch of doses was exhausted), patients who are older than the age range in the clinical trials, and a patient with an enormous (14 cm.) GBM tumor of which only half could be removed by surgery and the remaining half regressed with treatment by DCVax-L and nutritional support for the immune system (case study accepted for peer reviewed publication)."
Could this be what got Dr. Bosch to confirm attendance and be the subject of the symposium "Lessons from Long-Term Survivors"?
This kind of information is only as good as its source. IMO, there are none more creditable than sharpie. Thanks for sharing and thanks for all you do keeping us updated on all things NWBO.
Considering this is a two-year negotiation that happened without shareholders having any idea, it makes me wonder what else is planned; what other negotiations/deals/conversations/planning has been happening...
Really makes me rethink about the unexpected Walgreens presentation and DC-Vax reference and see it in a whole new light 🤔
Take a look at those beautiful dates 😍
Primary Completion (Estimated)
2025-08-22
Study Completion (Estimated)
2025-08-22
Closed .4977 HOD
I want to highlight that these trials also go a long way towards establishing creditability for management. If you recall from the 10-K - "The Company anticipates proceeding with such an initial combination during 2024 when it is able to free up sufficiently from the MAA review process and the inspections processes."
Well, here we are. Management is delivering on these words, which will make new investors more confident they will deliver on the rest. Also want to point out: interestingly they note this will take place after the "review process and the inspections processes". Seems we can infer we are now past "inspections processes" 🤔
I really like the idea of 3 (wow 3!) clinical trials using DCvax before striking any deal with BP. I think these types of collaborations with research institutes are being pushed by LP, so there won't be any risk of the technology getting buried by some BP or the chemo/radiation interests... I wouldn't be surprised it we get some more of these research trials in short order... anyone hear of large investments at UCLA
Bring on a couple more collaborations, bring on UK approval, then we could seriously looking at a BUYOUT on the horizon
And shortly thereafter, a surge of new job postings at Advent....
14 jobs posted. What's the hurry? 😅
I encourage you to check out DeepThought on Stocktwits. Well written and logical.
Just a few short weeks ago, I would have said people were being too optimistic with timelines. Just a few short weeks ago, I was going to comment we need to patient on the Nature article. Just a few short weeks ago, I would have said people are crazy to think we aren't getting an RFI.
Then this 10-K came out and the Nature article, and now I'm thinking there is a real possibility approval could come as soon as May. It not, it could truly be any day thereafter...
Lots of new job postings at Advent. Seems like they are anticipating something...
And if the company is now onto other business, does anyone recall what management stated comes next?
It does seem like the company has completed the intense work of responding to the MHRA and now have time to attend to other matters, notably the amended 10-K and the new loan.
I'm a buyer today
Just got this reply 2 minutes ago....
"Dave Innes
10:50?AM (2 minutes ago)
to me
Will let everyone know when we have selected a date.
Dave "
I am wondering if that wet cement dries March 21/22...
I like the new list of vacancies at Advent.
What happens next when all jobs are filled...?
Interesting line in new job posting...QC Scientist II...
"support product release, technology transfer and validation of new methodology"
Speculation:
1) product release...DC Vax?
2) technology transfer...CRL or Eden?
3) validation of new methodology...Eden?
Perfectly stated.
I truly hope one of the trials is a basket trial. I think that kind of announcement by itself could lead to a drastic share price increase because....well, just think of the possible indications it could open of DC-Vax to...
While I wholly agree with your reasoning and sentiment, I also want to note that the phase B expansion has been disclosed as completed, just this past summer (July if my memory is accurate). So it would seem that that expansion was already planned and implemented to possibly address the extra compassionate cases they expected. This hiring spree (I call it a spree because it's the most positions I have seen posted at the same time) seems to be in preparation for another milestone/catalyst. At this point, nothing can be confirmed. I just find the timing interesting and take the position that 150 days is just the end of a range and we will likely be approved before then maybe December or January.
I 100% think that the timing of the nature article pre-print and LL hiring by NWBO are directly related to the planning of upcoming trials. By releasing the pre-print, it allows LL(and NWBO) to discuss and reference otherwise non-public results with a BP. They will use this information to map out the future clinical trial details which will commence once DC-Vax is approved in UK. They will announce a partnership that will include those trial details at some point after MHRA acceptance, but before approval. This is my latest thesis.
Here...
Glioblastoma immunotherapy: time for hope?
Giacomo Sferruzza & Gaetano Finocchiaro
Neurological Sciences (2023)Cite this article
The DCVax-L study has recently shown a significant survival gain in glioblastoma (GBM) patients treated with dendritic cell (DC) immunotherapy versus an externally controlled cohort [1]. The initial case–control design of the study required modification partly because patients in the original control arm underwent apheresis and requested their cells to be used for immunotherapy at recurrence.
Notably, 79% of patients screened were excluded for different reasons (GBM diagnosis not confirmed, insufficient amount of tumor lysate for DC preparation but also disease progression or clinical deterioration) [2], raising concerns about biases.
The potential of external controls has been discussed by the Clinical Trials Think Tank of the Society of Neuro-Oncology with caveats on possible biases [3]. Part of these caveats was addressed by Liau et al. in their statistical analysis plan. To investigate this further, we compared the PFS data of control arms of included trials and DCVax-L patients, all treated by standard radiochemotherapy. We digitally scanned the published KM curves and reconstructed survival data from curve drops relative to the number of patients at risk (https://doi.org/10.1186/1471-2288-12-9).
The median PFS (mPFS) of the reconstructed curves was compared to the original studies, confirming the accuracy of the method. The control arm of the DCVax-L trial was analyzed against the pulled control arms of the comparator randomized clinical trials using the log-rank test and the R statistical package, version 4.0.3. The mPFS of control patients of the DCVax-L trial was 7.6 months (95% CI: 5.6–11.1; 5.6–10.9 months reported in the trial), compared with 6.0 months of the pooled control arms (95% CI: 5.6–5.7) (p-value?=?0.14; Fig. 1), not supporting the hypothesis of selection bias.
Fig. 1
figure 1
PFS of control patients treated by the standard of care (Stupp regimen) in the DCVax-L trial and control patients with the same treatment in the external trials used as comparators
Full size image
In the DCVax-L study, the survival advantage associated with DC vaccination is significant in GBM with MGMT methylation and at recurrence. We previously found a statistically significant co-occurrence of MGMT methylation and hypermutations [4] and a significant increase in CD8?+?T cells in GBM with increased mutational burden [5]. Indeed, some patients in the DCVax-L study with MGMT methylation may have benefited from DC immunotherapy because of increased persistent mutational burden and CD8?+?T cell density [6], but the hypothesis cannot be tested because of the lack of data on immune responses. Nevertheless, the long-awaited results of this study may give some hope to GBM patients and encourage further testing on the use of external data in clinical trials.
I also like to ruminate about the 13 positions recently posted and filled (except 1) at Advent. They hire 12 folks to hang around for 6 months waiting until approval? That doesn't line up timewise for me.
You called?
JTURDENCE - Another turd flushed down the toilet to the ignore bucket. In the words of Al Bundy: BOW-WHOOSH
I like the way you think. Real possibility!
Yes! Thinking the same thing...why mid-day announcement with dates still a ways out...? to allow for BP negotiations to finalize
Beautiful article! Nicely done. I hope the scum get what's coming to them.
White Knight or another White Lie?
Did you listen to Les's radio show appearance...? Basically renders all of your stories into fairy tales...
Care to comment?
I really like the way this was outlined and phrased and it make a lot of sense. I think your questions and unknowns are likely and exactly what folks should bet on is happening. Thanks for putting this together.
Fantastic news and great commentary!
Lots of new jobs at Advent including HR officer.
Appreciate the clarification.