Replies to post #656588 on NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

Not true. The trial results are what they are. PFS is a surrogate measure for accelerated trials that must later confirm with a phase 4 trial that PFS was a true surrogate for OS and not a mirage caused by pseudoresponse.

The company did not do an accelerated trial not because they failed PFS, but because the measure for PFS at the time was not calculated to address pseudorecurrence, what was learned later to be a common issue with immunotherapies. Seems when you induce an immune response to a tumor, you get inflammation, and when you can only evaluate through a crude single scan, and don’t give it time, you can misdiagnose the actual response to the treatment falsely as recurrence. It is only later measures which delay the finding for 6 months where you see that it was actually the response to the drug and not recurrence that you can validate it, or with a longer trial and proof of an improved survival response which then makes unnecessary the phase 4 confirmation that PFS correlated with survival that other trials have.

They had a longer trial and effectively obviated the need for the phase 4. Yes, they used an external control arm, and they addressed potential issues of bias by hiring a top notch outside consultant firm of esteemed epidemiologists and statisticians from University of Chicago to do a blind analysis of concurrent trials considering all the issues and to create a reasonable measure of the normal measures for placebo arms for trials that were similar and concurrent. This is a rare disease.

You can argue the regulators won’t accept it. That seems unlikely given the many other countervailing arguments that are much more compelling and more consistent with recent history for trials and especially for trials in rare diseases such as GBM.

The fact is, you don’t have much of an argument except to argue vacuous and empty matters of traditional form over reality and function. I don’t think those arguments are going to be compelling to any regulator given the proof which is broad and deep, that there is substantial benefit, it’s extremely safe and affordable, for a rare disease and took decades to validate and develop. The form over reality notion is just extremely doubtful at this point and there is more than just JAMA, there are other studies, other results. There is the side trials, previous trials and compassionate data. There is massive support from patient advocacy groups and doctors of eminent backgrounds. And the best doctors that even raised the form issue, were not calling for the rejection of applications. Nowhere did that occur, but it certainly is not the majority opinion even if those who blindly raise issues here while promoting Optune, a treatment which was approved by the FDA despite failing to prove any real benefit at all in it’s main trial that got it approved in the first place … device trials being what they are…and was approved without any placebo at all.

You waste our time, but the arguments get more easy the more times we make them.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6006274/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6175399/

[SkyLimit2022]

LC,



Thanks for reposting your opinions about PFS again, but I think you’re just throwing random mud. Actual PFS was subsequently proven by the OS data, but the predictive PFS data were contaminated and therefore the investigators could not use the predictive PFS data as a reliable surrogate predictor of OS. Instead, they had to wait for actual OS data.

Oncologists always attempt to measure and predict PFS as they should. Every cancer trial investigator will seek to predict PFS in advance of OS which of course takes longer to discover and confirm.

OS is the ultimate standard, but you cannot wait until death to begin evaluating whether a cancer drug is efficacious. The physician must evaluate a patient’s response and try to determine whether the treatment is helping.

Today, doctors have better methods for measuring progression, particularly when studying immunotherapy agents which are still relatively new as the emerging field of cell-based science is leading to rapid changes in the understanding of how cancer can be assessed and treated.

The P3 for the DCVax-L cell-based technology spanned many years. If the trial were designed and commenced in 2023, the investigators would appropriately attempt to measure progression and predict survival using the best methods and most current medical knowledge available in 2023, as any cancer researcher would.



Don’t forget to follow the combo trial! This study has a placebo design and revised methods for attempting to identify progression. More importantly, the interim survival data are brilliant!
https://clinicaltrials.gov/study/NCT04201873



Amid all of the misinformation and bad-faith disinformation pollution online, it is crucial that we refocus our attention beyond baseless social media posts to seek full-context credible sources and consult licensed oncologists…

JAMA Oncology is a peer-reviewed medical journal that us part of the Journal of the American Medical Association (JAMA) network, which is one of the most widely respected and influential medical journal publishers globally.

Being a peer-reviewed journal means that research articles submitted to JAMA Oncology undergo a thorough evaluation process by independent experts in the field before they are accepted for publication. This process helps ensure the quality, validity, and scientific rigor of the research presented in the journal.

Researchers, healthcare professionals, and the medical community rely on publications like JAMA Oncology for up-to-date and credible information in the field of oncology.

For a reliable appraisal of the DCVax-L P3 trial, its design, and the significance of the resulting survival data, it is advisable to refer to the analyses of qualified physicians. One such analysis can be found on the JAMA Oncology website where the link to the independent peer review and supplementary materials are published.

https://ceoworld.biz/2022/04/05/top-5-medical-journals-in-the-world-everyone-should-know-about/

This study found that autologous tumor lystate-loaded dendritic cell vaccination plus standard of care (SOC) was associated with improved survival in both newly diagnosed & recurrent glioblastoma compared with matched controls who received SOC treatment. https://t.co/Uso7Pkh1Kt

— JAMA Oncology (@JAMAOnc) February 15, 2023

https://finance.yahoo.com/news/northwest-biotherapeutics-announces-dr-linda-140000962.html

https://www.jci.org/articles/view/169314

https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers

https://hotb.org/wp-content/uploads/2022/05/spore-article-for-donors-4.18.22.pdf

https://www.uclahealth.org/news/brain-cancer-discovery-clinical-trials

Our team just met with the @NorthwestBio team to learn about #DCVax and had the pleasure of speaking with longterm DCVax patients. An honor and a privilege. #endbraincancer #sno2023 pic.twitter.com/dw3X76DBru

— EndBrainCancer Initiative (@EndBrainCancer) November 19, 2023

[KIPK]

LOL - Load of C poster commenting … lol you are USLESS & Irrelevant!

[drugrunner]

lol if JAMA holds up

a top 5 journal publisher in the world

Being questioned by an internet BASHER

Eye rolls

Can’t make up the level of BS being slung by the keyboard warriors today

Poor LC
Dumb as a box of rocks

[drugrunner]

LC do u even understand the definition of pseudo progression

ITS FALSE PROGRESSION

DISEASE PROGRESSION THAT DIDNT OCCUR