NorthWest Biotherapeutics Inc (NWBO)

[seekinganswers]

Roswell dumped off old antiquated DC tech to LP for pennies on the dollar, who was the only one dumb enough to buy it. ( WITH SH MONEY - just more breadcrumbs to keep diluting on an almost daily basis)
Roswell is moving forward full steam ahead with SurVaxM.
DCVax is dead, UCLA is running ATLDC trials with the Jonsson Center, and will likely never do business with NWBO ever again after the 25 year debacle with DCVax.
I'm looking forward to seeing the 10K when it finally comes out. 😎

https://www.sciencedirect.com/science/article/pii/S0035378723009190

https://pmc.ncbi.nlm.nih.gov/articles/PMC10076936/

Conclusion
This dendritic vaccine trial has several limitations. These limitations include changing the primary endpoint (OS instead of PFS), creating a new study population (recurrent glioblastoma), conducting unplanned analyses, using external controls in a design originally intended to be randomized, all changes occurring years after the trial finished enrollment. The selected external controls likely included patients with less favorable outcomes, which opposes the “fit-for-purpose” criteria usually applied in selecting external controls. Therefore, the purported survival benefit from the vaccine is unreliable. The accumulation of limitations, along with multiple changes made over nearly two decades; further hamper the reliability of the reported results. Without data sharing, those concerns cannot be alleviated. Glioblastoma is the most common primary brain tumor, and there is no valid reason to stray from the gold standard of a randomized-controlled trial with overall survival as the primary endpoint in order to change clinical practice. Dendritic cell vaccination is a very promising approach for GBM, the neuro-oncology medical community can only regret that due to the described DCVax-L trial weaknesses, we cannot draw any conclusions on potential efficacy.

What can be learned from this? The trial design allowing “cross-over at progression” prevented the use of OS as the primary endpoint. This is still the “gold standard” endpoint in oncological phase III studies, and PFS is indeed a problematic endpoint in trials on newly diagnosed glioblastoma. Despite the argument used to allow cross-over at the time of the study design, a more general question is whether cross-over designs may actually obscure the signal of activity of the investigational agent by interfering with endpoint analyses. If so, not allowing cross-over will result in a more robust trial design and the more robust the trial design, the larger the likelihood results will translate quickly into a modified and superior standard of care if the trial is positive. Then, the investigators can be criticized for not taking an obvious step: the data presented in 2018 are basically the same and if that signal was conceived as positive, a dedicated well-designed 2nd trial would have been the real answer instead of a round of intrinsically flawed data constructions. Post hoc analyses are hypothesis generating and nothing else.

To conclude, stringently designed and executed prospective randomized clinical trials remain the gold standard for evaluation of efficacy of novel treatments. Control of known, but also unknown, confounders are crucial in clinical trials, and the present analyses of the DCVax-L trial offer neither. Further methodological research and definition of standards that ensure adequate scientific rigor is needed to define the possible role of externally controlled clinical trial data for retrospective analyses or within prospective clinical trials. This concerns both healthcare and regulatory decision making in (neuro-)oncology.

Just my opinions, GL to all.