Yes, thank you—the trial was a brilliant success and the independent peer review is forthcoming.
Most recent news and events:
Dr. Ashkan, a world-renowned clinical trial expert and an advisor to the U.K. government, presents DCVax P3 data.
https://soc-neuro-onc.org/ Autologous tumor lysate-loaded dendritic cell vaccination improves survival in patients with newly diagnosed and recurrent glioblastoma: survival results from a phase 3 trial Plenary Abstract Presenter: Linda M. M. Liau, MD PhD - University of California, Los Angeles
https://nwbio.com/press-releases/ On August 17, the Company received final approval of the Pediatric Investigation Plan (PIP) from the MHRA. The final regulatory approval of the PIP must be obtained before a sponsor may submit a Marketing Authorization Application (MAA) for approval to commercialize the new medicine for adult patients. The Company’s approved PIP includes a deferral under which the pediatric trials are anticipated to be undertaken after an MAA application has been submitted. Patients will be treated with DCVax-L on the same treatment schedule as in the Company’s Phase III trial in adult glioblastoma patients.
The primary endpoint for each of the 2 pediatric trials will be overall survival, determined by comparing the survival of DCVax-L treated patients to matched contemporaneous external controls. The external controls will be identified using the same methodology as was used to pre-specify the external controls in the Statistical Analysis Plan for the Company’s Phase III trial in adult patients.
UCLA Presentaion DCVax is discussed beginning at minute 40, to focus on Keytruda (pembrolizumab) plus DCVax in combo at UCLA, skip to minute 45:40
Who cares about the outdated statistical primary endpoints Yes, the primary statistical endpoints were the original objective, but the true results have proven the fact that the OS data results are the living proof that DCVax-L works and that is where confounded individuals fail to understand the truth of the matter. The truth prevails as DCVax-L is both effective and should be available to help cancer patients in need, IMPO.
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