Replies to post #519071 on NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

Research this for yourself: The successful global P3 DCVax trial was conducted at 94 sites worldwide and was designed and led by two CLINICAL TRIAL EXPERTS, both who have been directly supported by their respective government’s regulators. The support of regulators is ongoing.

Dr. Linda Liau is a world-renowned neuro-oncologist, surgeon, and educator at UCLA where she is also the chair of the department of neurosurgery. As her paper on DCVax moves through the independent peer review process, it is interesting to note that she was once the editor-in-chief of a neuro-oncology medical journal.

https://www.uclahealth.org/providers/linda-liau

https://doi.org/10.3171/2020.12.FOCUS20954

https://soc-neuro-onc.org/

Across the pond from Dr. Liau, Dr. Ashkan was the chief investigator of the DCVax trial for patients in Europe. At King’s College in London, Ashkan is the lead clinician for neuro-oncology and the chair of the King’s Neurosciences Clinical Trial Unit. He is a world-renowned cancer trial expert. A few years ago, Professor Ashkan was named the UK Clinician of the Year by The Brain Tumour Charity. Additionally, Ashkan serves as an advisor to the U.K. government.

https://www.kcl.ac.uk/people/keyoumars-ashkan

https://virtualtrials.org/dcvax.cfm

Fact check:
These are the “types” that are posted on clinicaltrials.gov: “investigational” and “observational.” Either of these could be adaptive. To date, “adaptive” is not a distinct and separate “type” for any clinical trial in the U.S. in terms of the nature of studies as they are currently registered on the NIH clinical trial registry.

“Type”
describes the nature of a
clinical study. Study types
include interventional studies
(also called clinical trials),
and observational studies
(including patient registries)
and expanded access.

https://clinicaltrials.gov/ct2/about-studies/learn
https://virtualtrials.org/dcvax.cfm

[biosectinvestor]

First of all, you've changed the subject.

I never commented on trial length. Yes, BP has no time for tying up their money for a long trial measuring OS, so yeah, they'd probably not be involved in validating this kind of technology. Their tendency is to let the small guys take all the risk with new technologies and then they buy the drug if it's successful.

I would expect that MOST people would know that already.

The length of the trial had to do with a few factors including the financial crisis in 2008, so yeah, BP typically has steady income, even during downturns, and usually they also don't put trials on hold. Not really a statement on capacities of management nor the validity of the clinical trial, in fact.

And again, about "complete", the comment was not about how long the trial went but on changing the endpoints. And yes, some BP trials have gone through something similar in terms of updating their SAP because they learned something during the trial that made a different measure a more effective and better measure of impact.

I don't think anyone else really questions, reasonably, that measuring OS is not objectively a much more solid, certain and better measure than the surrogate measure of OS by way of PFS. Since the FDA wants OS, and PFS is a surrogate measure intended to get at a faster and more expedient result, validated frequently later by OS data on a phase 4 trial, when a company just basically goes all the way out and measures OS, which takes a long time in the case of oncology, where a drug is effective, and where a company is small and accumulates patients over a long time, the result is still likely viewed as valid and superior, in fact, to an expedient trial that measured a surrogate end point that may or may not be a valid surrogate for OS in that particular case. And let's not forget the phenomenon of pseudoresponse.

https://radiopaedia.org/articles/tumour-pseudoresponse?lang=us

Tumor pseudoresponse, also known just as pseudoresponse, refers to the phenomenon of tumors appearing to respond to a specific treatment on imaging criteria when the lesion actually remains stable or has even progressed.

[dstock07734]

Do you really believe "BP is far better at designing and executing trials."? If you do, that certainly doesn't bode well for NVCR.

Here is a trial sponsored by Bristol-Myers Squibb and NovoCure.

https://clinicaltrials.gov/ct2/show/NCT03430791?cond=glioblastoma+++Opdivo&draw=2&rank=5

But the trial was terminated last year because BP is far better not only designing and executing trials but telling the good trials from the bad ones.

Now the trial solo sponsored by NVCR is almost predictable.

https://clinicaltrials.gov/ct2/show/NCT03405792?cond=Glioblastoma+%2B+Pembrolizumab&draw=4&rank=11

Good luck to you.