Replies to post #603938 on NorthWest Biotherapeutics Inc (NWBO)

[Dr Bala]

This nonsensical post is due to lack of understanding of the FDA Oncology AOO 2022 guidance and the JAMA article.

[SkyLimit2022]

HyGro,

Thanks for reosting your perspective again about the FDA and MHRA.

The DCVax-L cell-based technology has been under clinical investigation for a significant period of time, and the overall clinical data in total include three trials spanning many years. Safety and efficacy data have been gathered from trials with external controls and trials with placebo controls. The data include DCVax-L as a monotherapy and in combination with other agents.

https://www.fda.gov/media/120721/download



https://clinicaltrials.gov/ct2/show/NCT04201873

The interim PD1 combo data are brilliant, and the trial is significant for a number of reasons relating to FDA guidelines and NIH peer-reviewed grant funding.

In the combo trial, patients who receive DCVax-L + placebo are being compared to patients who receive DCVax-L + pembrolizumab.

The control arm is receiving DCVax-L. While DCVax-L is not the current SOC, it is highly significant and notable that DCVax-L is being permitted to fill the role of SOC as the best available therapy within this combo study for rGBM. The combo trial also follows the P3 in sequence which in itself validates the findings of the P3 study—the placebo group in the PD1 study would not be receiving DCVax-L today if the preceding P3 trial had not proven its efficacy.



The NIH is the most significant player in this game—If they had any doubt about the P3, the NIH would not continue their support and the FDA would not have permitted the combo trial to commence or continue.

https://clinicaltrials.gov/ct2/show/NCT04201873

The U.S. NIH has supported the DCVax-L platform for years, and the NIH renewed its support in 2022 to continue to fund the development of this technology and to fund research into combination therapies.

NIH-funded DCVax-L research is ongoing at UCLA today.

NIH grants are peer-reviewed and the research that NIH funds is highly scrutinized in advance of the award and also intermittently for the term of the various research projects.



Mr. Newirth is another DCVax-L survivor well surpassing 10 years following a 2012 diagnosis! Congratulations!

https://www.hawaii.edu/news/2017/03/30/newirth-laker-for-a-day/

June 13, 2023 Interview:

https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers

https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/

https://www.theguardian.com/science/2022/nov/17/im-just-carrying-on-vaccine-gives-brain-cancer-patient-years-of-extra-life

https://www.braintumourresearch.org/stories/in-hope/in-hope-stories/kat-charles

https://www.uclahealth.org/news/brain-cancer-discovery-clinical-trials

https://www.uclahealth.org/news/ucla-received-590-million-in-nih-funding-second-highest-total-for-academic-medical-centers-in-2020



https://www.fda.gov/science-research/advancing-regulatory-science/fda-nih-joint-leadership-council-charter

[SkyLimit2022]

HyGro,

Thank you for highlighting the topic of the MHRA! I would like to add a reminder to this conversation about the highly significant recent developments:

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172038107

[Doc logic]

HyGro,

So generous of you to concede MHRA approval; ). That, of course would put pressure on FDA if FDA was reluctant to approve which does not appear to be the case really since so much of the recent guidance changes revolve around the advances in understanding of how broad in scope immunotherapy can reach. Keeping 17 SOC/placebo patient out of the Phase 3 trial while all patients in the treatment arm were enrolled also strongly suggests that FDA knows this treatment works and is why JAMA Oncology published the results and conclusions of this L Phase 3 trial.
Now if you want a possible explanation for delays to approval that is easy. Demand will be overwhelming for this PLATFORM treatment once approval is given for GBM which was expanded to include rGBM and seems to have been expanded again into the tissue agnostic reality that this PLATFORM represents. This means Edens needs to be ready and regulation of product release needs to get streamlined for personalized medicine. Governments tend to be slow making these kinds of adjustments.
Dr. Bosch reiterated recently what NWBO has been saying about their PLATFORM and the science has been saying this for a very long time.
The process of DC activation/maturation is the same for all cancer types and all diseases in general. This process is done in the body all the time with no thought given to it except when there is a breakdown in proper activation/maturation such as is the case with cancer that hides behind normal cells and or signals the all clear sign to the immune system. NWBO has found a way to correct for this deception and soon will clear a pathway to the truth behind the spoofing deceptions created by those whose interests do not align with cancer patients or investors in companies like NWBO which are seeking to help them. Best wishes.