As usual, your postings always remind me of the most relevant fact regarding the exemplary global P3 and how it was carried out over the years to its successful completion: The P3 was designed and led by clinical trial experts, both with long-standing connections to their respective government’s regulators. Liau has been directly supported by FDA-NIH NCI for 20 consecutive years and continues to receive their support.
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.
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.
No immunotherapy (vaccine or ICB) has worked in GBM as the CNS is immunologically privileged. DCVax has overcome the immunosuppressive environment and is the 2nd clinical trial recently to reach significance in GBM. More to do but a good step forward.
Why does NWBO continue to pour energy and moneys into beefing-up and securing licenses for DCVAX volume manufacturing capabilities if the phase-3 is confounded and a bust and they know it?
Northwest Biotherapeutics Announces Filing of Application for License for Commercial Manufacturing at Sawston, UK Facility
The only confounding you can’t get past is if your own making. The rest you point to has all been dealt with through the exceptions to adequate and well controlled trials. Feel free to read up and highlight the relevant parts that NWBO has been working through. Best wishes.