NorthWest Biotherapeutics Inc (NWBO)

[Chiugray]

Gary, On the question is getting DCVax post-approval onto the Compendium (NCCN) for off-label use.

Here’s some general information I found.
Compendium Review Committees for cancer drugs: composed of oncologists and specialists

Goal: provide the health care provider and the patient information to make informed choices when selecting systemic therapies based upon measures related to treatment, supporting data, and cost.
https://www.nccn.org/guidelines/guidelines-with-evidence-blocks#:~:text=For%20efficacy%20and%20safety%2C%20panel,patients%E2%80%94and%20their%20clinical%20experience

Guidelines are evidence- and consensus-based clinical practice guidelines addressing malignancies that affect more than 97% of all patients with cancer in the United States.

Guidelines are used extensively in the United States and globally. (i.e. used by insurance payers for coverage)
https://pubmed.ncbi.nlm.nih.gov/24812133/

My opinion is:
YES

My thinking:
Demand from cancer patients:
DCVax-L uniquely is a broad-spectrum cancer vaccine profile, efficacious, non-toxic, broad-based immune response, leaves behind robust immune memory (prevent metastases and recurrence), enables adding combo adjuvant drugs, and potential for cure.

Demand from insurance companies:
Non-toxic profile reduces healthcare costs broadly. Imagine the potential to avoid an entire layer of secondary treatments and costs resulting from side effects of a toxic primary drug, like chemotherapy for example.

Demand from oncologists:
73 oncologists globally co-authored JAMA publication

No downside.

DCVax’s mountain of evidence and consensus:
Marnix Bosch: “used it to date to treat almost 600 patients with GBM, both in clinical trials, and in compassionate use programs, and also tens of patients with other cancers, including: Merkel cell carcinoma, breast cancer, thyroid cancer, and several others”

JAMA publication – DCVax was “clinically meaningful and statistically significant extension of survival for patients with both nGBM and rGBM”, co-authored by 73 global oncologists

Nature publication – DCVax combined with adjuvant was “safe and enhance systemic immune response”

Food for thought
Marnix Bosch said at the beginning of his 6/3/2023 presentation:
“I truly believe that we're at the beginning of a revolution here, where hopefully, five or ten years from now, there will be no more need for placebo-controlled clinical trials, because really, in the end, once you know, sort of, what the outcome is of a disease, especially if the patients are given standard of care, at some point, there will be no more need for placebo controls, and all patients will be able to participate in the new inventive treatments that we’re coming up with. And we think that's an important development, and we're happy to be one of the leaders in that particular field.”