Thanks for reposting your opinions again. Please consider the sources linked below and research whether there is anyone more experienced, talented, and qualified to conduct a cancer study than Dr. Liau and Dr. Ashkan.
Additionally, explore the links below relating to Dr. Pazdur of the FDA. Research how the external contemporaneous controls were selected by an independent firm. The crossover was not only approved by the FDA as clinically appropriate, it was required.
The P3 was designed and led by these two 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. In fact, Dr. Liau has authored over 170 peer-reviewed articles, several book chapters, and a textbook entitled Brain Tumor Immunotherapy. She is on the editorial boards of several scientific/medical journals and was the Editor-in-Chief of the Journal of Neuro-Oncology (2007–2017).
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.
Now we are in the era of immunotherapy" -Richard Pazdur, MD
"Often, novel agents are so obviously superior to standard of care that no patient would participate in a randomized trial knowing that somebody else might get the experimental drug -Richard Pazdur, MD
"There's also been a revolution in tumor immunology. Before, in my early career, tumor immunology was looked at kind of as black magic, as witchcraft. Now it's accepted." -Richard Pazdur, MD
"When we make a decision about approving a drug, it has to be patient centered. It can't be about the regulations" -Richard Pazdur, MD
Some of the best advice ever "Don't listen to social media" With respect to NWBO 1) TLD better than expected based on the OS data results 2) Dr Linda Liau and her team are one of the top leaders leading the way in GBM brain cancer research. 3) Manufacturing is moving forward. 4) GMP approval prior to the end of this year, weeks not months 5) MIA and MA soon afterward. NWBO continues to forge a positive path forward.
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