Replies to post #519885 on NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

Yes, we are excitedly and confidently awaiting their verdict. And the issues were addressed and caused by limitations in technology and understanding and ethical requirements. They were properly and adequately addressed by appropriate changes, not “manipulations” (you can’t manipulate survival data in this case), and I expect those changes were implemented with the guidance and advice of their regulators.

The best run trials, like this one, it is typical to stay in close contact with regulators during the trial, and even if it is not formal advice and there are no guarantees from those at the agencies, it is still likely, in my opinion, that they were discussing and confirming procedures with regulators every step of the way as well as with their legal counsel.

Advising post data lock from bulletin boards, Hygro, won’t change the results.

[CrashOverride]

MHRA already endorsed the trial design while the FDA has many opportunities to reject it including SAP and clinicaltrials endpoint updates.

[sentiment_stocks]

Which is your opinion - that you think NWBO manipulated its P3 trial data.

Obviously, that's not my opinion.

Giving your opinions as to what you think about the trial data, the company management, and the vaccine is completely on topic for this board.

Offering your opinions about other posters' opinions is also allowed, for the most part, so long as is it's done in a civil manner.

Things not considered not appropriate would be topics like investment advice, such as you (especially when singled out to one particular poster) should buy or sell this stock, but those are often excused, depending upon the manner they are offered, and the any particular moderator's opinion of such a post, IMO.

[SkyLimit2022]

Thank you reposting your comments about the regulators once again. Yes, you are correct that the FDA will play a crucial role and already has been an important part of DCVax development…

The U.S. government (FDA-NIH NCI) is largely responsible for the invention and development of the DCVax platform technology. The 20 consecutive years of NIH funding of Dr. Liau have played a direct and crucial role in DCVax. Together with Merck, NIH is funding the DCVax doses going into arms TODAY in a study investigating its efficacy in combo with Keytruda.

FDA has approved multiple DCVax trials and their design including the ongoing Keytruda trial.

September 14, 2022 Update of NIH NCI Funding of Dr. Liau

https://connect.uclahealth.org/2022/09/14/brain-cancer-discovery-clinical-trials/

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

https://www.bentley.edu/news/nih-funded-research-related-every-new-cancer-drug-approved-2010-2016

9/14/2022
In a trial now underway, a dendritic cell vaccine is made from a participant's own tumor tissue and combined with an anti-PD1 immune checkpoint inhibitor to counter resistance when either treatment is used alone. The checkpoint drugs work by blocking the proteins that stop the immune system from attacking cancer cells.

"What I'm excited about is that we're seeing a growing number of long-term survivors in our patients treated with immunotherapy combinations," Dr. Liau says. "We're seeing some patients with certain combination immunotherapies that are living for many more years than would be expected. Currently, we're trying to find out what combination works best and for which patients."

https://cancer.ucla.edu/research/ucla-brain-spore

https://www.merck.com/stories/fighting-cancer-requires-an-open-mind/

Merck: “Personalized cancer vaccines which are therapeutic vaccines based on patients’ specific cancer that could potentially prime the immune system to recognize certain characteristics and attack the cancer cells”

DCVax is discussed beginning at minute 40, to focus on Keytruda (pembrolizumab) plus DCVax in combo at UCLA, skip to minute 45:40

NCI, Merck, & PHASE ONE are today supporting collaborators on the UCLA Keytruda trial—100% of patients in both the experimental group AND the placebo group receive DCVax. Only Keytruda in combo is being investigated—everyone receives DCVax as if it were SOC.

Group A (pembrolizumab, ATL-DC, poly ICLC)
Beginning 14 days prior to scheduled surgery, patients receive pembrolizumab IV over 30 minutes. After surgery, patients receive pembrolizumab IV over 30 minutes on day 1. Cycle repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive ATL-DC ID with poly ICLC IM every 2 weeks for up to 3 doses in the absence of disease progression or unacceptable toxicity.

Group B (placebo, ATL-DC, poly ICLC)
Beginning 14 days prior to scheduled surgery, patients receive placebo IV. After surgery, patients receive placebo IV on day 1. Cycle repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive ATL-DC ID with poly ICLC IM every 2 weeks for up to 3 doses in the absence of disease progression or unacceptable toxicity.

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

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.

https://www.uclahealth.org/providers/linda-liau

https://doi.org/10.3171/2020.12.FOCUS20954

https://soc-neuro-onc.org/

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.

https://www.kcl.ac.uk/people/keyoumars-ashkan

https://virtualtrials.org/dcvax.cfm

Richard Pazdur, M.D. is the director of the FDA's Oncology Center of Excellence (OCE), which leverages the combined skills of the FDA's regulatory scientists and reviewers with expertise in drugs, biologics and devices to expedite the development of novel cancer products. In his role as director of the OCE, Pazdur is responsible for leading the effort to develop and execute an integrated regulatory approach to enhance the cross-center coordination of oncology product clinical review.

Pazdur has published more than 400 articles, book chapters and abstracts. In 2015, Fortune magazine named Pazdur as one of the 50 World’s Greatest Leaders. The American Association for Cancer Research recognized Pazdur with its Distinguished Public Service Award (2015) and the American Society of Clinical Oncology recognized him with the Service Recognition Award (2009) and the Public Service Award (2013). In 2015, Pazdur also received the Public Service Leadership Award from the National Coalition for Cancer Survivorship and also the Face of Hope Award from the LUNGevity Foundation. Most recently, in 2016, Pazdur was named to Massachusetts General Hospital Cancer Center’s “The One Hundred” list.

"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

https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext

https://www.fda.gov/drugs/news-events-human-drugs/50-years-progress-treating-patients-cancer

https://www.webmd.com/cancer/cancer-in-context/video/richard-pazdur

https://www.onclive.com/view/pazdur-followed-the-pathway-of-greatest-resistance-to-the-fda

So many of these survivor stories are old news— research 2022 updates—some are GBM patients surpassing a decade or multiple decades—miraculous …

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