AI
Sunday, January 15, 2023 3:04:17 PM
Thanks for reposting your opinion again. The statistical analysis plan was approved by the regulators. Ashkan is a careful and precise brain surgeon—listen to his words:
Dr. Ashkan said this in June 2022. Skip to timestamp 14:55 of the ASCO video.
Dr. Ashkan was the chief investigator of the murcidencel 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://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
https://cdn.jamanetwork.com/ama/content_public/journal/oncology/0/coi220066supp1_prod_1668698380.81699.pdf?Expires=1676780989&Signature=I5OpHDA5H3FIhuKxdijPEWnsIIQq5zwNcKvqL6P5Rjy8uumxSPgPb6sc1Uhl2Wd5mP9GTcsZoXzSlU8Pf2pclbrBsWmZiTnkWo0zhvIql90z~mj5MXSYPZ3gQ0~PQBiPDuTlDqz4xMimD33hw45NPJ6B6oRoWYMxsCI-i6Rb3ZSi3g6Iq5~c~Y8QK5CwrPjd3cnN8qcGvERrm0dDqKfRtDYbWj84UsmsdXKw260NwhXHLJjZPEn2EkM3L~ClimScT7ASS9Tcpkoz8Ttw7sf4fe6Iei-Y6hdgg1tY~Tx~zYMftcTOSNQrE3bcxfVcfL7ID0jE5zCGgf1DO9pbbhfrUQ__&Key-Pair-Id=APKAIE5G5CRDK6RD3PGA
Anyone can research the original FDA approved design that allowed crossover. FDA knew from the start that the placebo patients might all crossover, and the FDA approved the trial to proceed with a crossover design. Thinking logically, why should we now assume that FDA will have a problem with the crossover?
The FDA mandated crossover for trial participants suffering from GBM.
Skip to timestamp 8:01. Dr. Liau again confirms that the crossover was mandated by the FDA.
https://edhub.ama-assn.org/jn-learning/audio-player/18738384
Anyone can research to verify that PFS is a surrogate for OS and only used because its data is accessible sooner than OS. When and if OS is reached, OS data either confirms or disproves the accuracy of PFS as a surrogate and as a PREDICTOR of survival. Furthermore, OS was always an endpoint along with PFS.
Statistical analysis accounts for all factors. The JAMA peer review validated the data and its significance, and there will also be an FDA advisory analysis.
The MHRA in U.K. approved the trial design and its endpoints twice—once for the adult trial and now again for the pediatric trials:
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.
The pediatric approval is full approval and immediately actionable. There is no requirement for adult approval or any prior application for adult approval for the pediatric trials to commence, however, the company has indicated that they will submit an application for adult commercial approval first. The second approval of the same trial design bodes well for the forthcoming adult application.
https://www.nice.org.uk/guidance/indevelopment/gid-ta10143
Dr. Ashkan said this in June 2022. Skip to timestamp 14:55 of the ASCO video.
Dr. Ashkan was the chief investigator of the murcidencel 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://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
https://cdn.jamanetwork.com/ama/content_public/journal/oncology/0/coi220066supp1_prod_1668698380.81699.pdf?Expires=1676780989&Signature=I5OpHDA5H3FIhuKxdijPEWnsIIQq5zwNcKvqL6P5Rjy8uumxSPgPb6sc1Uhl2Wd5mP9GTcsZoXzSlU8Pf2pclbrBsWmZiTnkWo0zhvIql90z~mj5MXSYPZ3gQ0~PQBiPDuTlDqz4xMimD33hw45NPJ6B6oRoWYMxsCI-i6Rb3ZSi3g6Iq5~c~Y8QK5CwrPjd3cnN8qcGvERrm0dDqKfRtDYbWj84UsmsdXKw260NwhXHLJjZPEn2EkM3L~ClimScT7ASS9Tcpkoz8Ttw7sf4fe6Iei-Y6hdgg1tY~Tx~zYMftcTOSNQrE3bcxfVcfL7ID0jE5zCGgf1DO9pbbhfrUQ__&Key-Pair-Id=APKAIE5G5CRDK6RD3PGA
Anyone can research the original FDA approved design that allowed crossover. FDA knew from the start that the placebo patients might all crossover, and the FDA approved the trial to proceed with a crossover design. Thinking logically, why should we now assume that FDA will have a problem with the crossover?
The FDA mandated crossover for trial participants suffering from GBM.
Skip to timestamp 8:01. Dr. Liau again confirms that the crossover was mandated by the FDA.
https://edhub.ama-assn.org/jn-learning/audio-player/18738384
Anyone can research to verify that PFS is a surrogate for OS and only used because its data is accessible sooner than OS. When and if OS is reached, OS data either confirms or disproves the accuracy of PFS as a surrogate and as a PREDICTOR of survival. Furthermore, OS was always an endpoint along with PFS.
Statistical analysis accounts for all factors. The JAMA peer review validated the data and its significance, and there will also be an FDA advisory analysis.
The MHRA in U.K. approved the trial design and its endpoints twice—once for the adult trial and now again for the pediatric trials:
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.
The pediatric approval is full approval and immediately actionable. There is no requirement for adult approval or any prior application for adult approval for the pediatric trials to commence, however, the company has indicated that they will submit an application for adult commercial approval first. The second approval of the same trial design bodes well for the forthcoming adult application.
https://www.nice.org.uk/guidance/indevelopment/gid-ta10143
Bullish
Believe carefully. This is the greatest and most powerful lesson that I have learned since arriving on Earth. Examine what you believe about yourself most importantly, and then believe carefully as you interact with the world.
