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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.
I'm noticing an glaring inconsistency...
I work in the medical field and specialize in mergers and and acquisitions and Post Merger Integration (PMI) 591287
and
during a merger...I am not a expert in this field...My expertise is biochemistry/bioengineering- Lab Supervision 571134
Do you care to clarify which one is BS?... I bet it's both.
Yes, totally full of BS. Desperation before pending reversal. Lots to come in May.
Bought today.
First comes volume, then comes price. Today we got volume, next week we get....
Increased my position 10% today
May those April showers bring May flowers
Advent job listings down to 1. Last time I checked there were 4.
Thanks for this outstanding post!
Quick question... If I understand the things correctly...Cohen has NOT asked for this extension, yet the judge still granted it in part...
Based on your inference that the judge is telling Burck: 1) I will deny the MTD and 2) slapped the wrist...
Is the judge saying to both parties (with emphasis to Burck)...you had better read between the lines and settle now, otherwise, all this goes to discovery...?
Might we get a settlement by March 15th?
10-k out
That is really well written...
Very interesting! Thanks for putting that timeline together.
This is very interesting. I'm sorry, but I can't help but read between the lines....
And, considering NWBO must have known a hit piece was about to follow, considering I read somewhere that LL was quoted. No way she wouldn't have relayed that info to NWBO.
Some observations:
No mention from the company about SNO presentation
No updates to website; still old/stale information
No 8-K for results
No ASM announcement
Wow! Very interesting....
Quality Assurance Regulatory Manager
job posting
"The QA Regulatory Manager will be responsible for submission of any relevant document to regulatory authorities that govern ATMPs, and cell therapy manufacture in the UK. This will include HTA, MHRA, JACIE and ISBT. The job holder will lead in preparing the site for Regulatory inspections, and maintenance of regulatory standards."
Perfect! I was hoping it was as positive as you stated. Thanks for confirming!