NorthWest Biotherapeutics Inc (NWBO)

[ae kusterer]

SALIENT RESEARCH :

pgsd

Re: None

Monday, October 03, 2022 2:20:43 AM

Post#
518586
of 518592

???? The Danish Dude ???? (Madam/Your highness)
@FlemmingBruce
$NWBO

What did Linda Liau say in an interview, 2 years ago?
Comment 1:

https://twitter.com/FlemmingBruce/status/1576557919042093057

DONE. Flaskworks has managed to do, what Liau means is lacking.

https://billmalloy.info/qa-with-linda-liau/

pgsd

Re: None

Monday, October 03, 2022 6:42:59 AM

Post#
518590
of 518593

Excellent post, in the passage of time some key and positive factors are forgot or overlooked.

NW Bio’s Phase III Trial With DCVax®-L For Brain Cancer “Adopted” As A National Priority Trial In UK

Cred54675419C's avatar
c red @Cred54675419C
1h
Replying to @TodosInvestor @FlemmingBruce @WayneLee1983
The UK government has set a goal of making the UK a world leading innovator in medicines.

FlemmingBruce's avatar
???? The Danish Dude ???? (Madam/Your highness)
@FlemmingBruce
Replying to @Cred54675419C @TodosInvestor @WayneLee1983
Great info @Cred54675419C ??

The NIHR maintains a “portfolio” of clinical trials that have
been “adopted” as high priorities for the UK. In order to be
selected for the NIHR Portfolio, a proposed clinical trial must go
through multiple layers of review and evaluation. The
evaluation includes the potential significance of the new medical
technology being tested, the quality of the trial design, the
feasibility of the trial, and numerous other factors.


Trials that are selected (“adopted”) for inclusion in the NIHR Portfolio are monitored closely by
the NIHR and the trial sites receive several types of financial and operational support. For
example, the NIHR provides resources and funding for additional staff (e.g., nurses) at the trial
sites to help accelerate the trial. The NIHR also oversees the performance of the sites, and
imposes penalties on the sites for shortfalls such as lags in enrollment.

“We understand that it is relatively rare for a small biotech company to have its clinical trial
‘adopted’ into the NIHR portfolio, especially a Phase III trial,” noted Linda Powers, CEO of NW
Bio. “This important validation of our trial is an exciting development, and the extra resources
and support from the NIHR to the trial sites will be very helpful in accelerating our trial.
https://nwbio.com/nw-bios-phase-iii-trial-with-dcvax-l-for-brain-cancer-adopted-as-a-national-priority-trial-in-uk-2/

SkyLimit2022

Re: dr_lowenstein post# 518567

Sunday, October 02, 2022 10:39:01 PM

Post#
518569
of 518593

Maybe you’re right—and maybe DCVax patients are paid to be alive too.

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/

https://m.youtube.com/watch?v=K9azZaIwOH8&feature=youtu.be
SkyLimit2022

Re: HyGro post# 518554

Sunday, October 02, 2022 9:54:46 PM

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518560
of 518594

NVCR made some specific statements too in their February 24th 2022 SEC filing. Their risk disclosures start on page 26 of the NovoCure filing posted below. You stated that SEC filings are submitted under penalty of perjury and should be considered by investors. I tend to believe that the documents as a whole are important, but we could follow your lead and pluck out some interesting risk statements to publish in isolation. What do you think?

https://d18rn0p25nwr6d.cloudfront.net/CIK-0001645113/c5eca622-306f-417f-931b-c2ab018fa6b6.pdf#page25

SkyLimit2022

Re: HyGro post# 518556

Sunday, October 02, 2022 9:57:01 PM

Post#
518561
of 518594

Thank you for again again again reminding us about Pazdur’s position on this point:

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

"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

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 previously served as the director of the Office of Hematology and Oncology Products (OHOP) in the FDA’s Center for Drug Evaluation and Research and will continue to serve in OHOP as acting director. This Office was formed in 2005 to consolidate the review of drugs and therapeutic biologics for the diagnosis, treatment, and prevention of cancer, as well as the review of drugs and therapeutic biologics for hematologic diseases and for medical imaging. As director of OHOP, Pazdur facilitated coordination of oncology activities across all FDA Centers and ensured an ongoing outreach and collaboration between the FDA, the National Cancer Institute, and other cancer-related organizations within and outside of the government. Pazdur was the director of the Division of Oncology Drug Products from September 1999 to May 2005.

Prior to joining the FDA, Pazdur was professor of medicine at The University of Texas M.D. Anderson Cancer Center in Houston, Texas. Pazdur was on the faculty of the M. D. Anderson Cancer Center from 1988 to 1999. During his tenure at the M. D. Anderson Cancer Center, Pazdur held administrative positions of assistant vice president for academic affairs, associate director of clinical trials administration (Division of Medicine) and director of educational programs (Division of Medicine). Pazdur served on the faculty of Wayne State University, Detroit, Michigan from 1982 to 1988.

Pazdur received his bachelor’s degree from Northwestern University (Evanston, Illinois), his M.D. from Loyola Stritch School of Medicine (Maywood, Illinois), and completed clinical training at Rush-Presbyterian St. Luke’s Medical Center (Chicago, Illinois) and the University of Chicago Hospitals and Clinics.

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.

https://virtualtrials.org/dcvax.cfm

SkyLimit2022

Re: HyGro post# 518555

Sunday, October 02, 2022 9:59:12 PM

Post#
518562
of 518594

Thank you for again highlighting the exemplary trial design—compassionate, clinically appropriate, adaptive, and representative of DCVax as an innovative new platform technology.

The trial design and its endpoints were approved by regulators multiple times. Each country or union of nations has its own RA—Canada, Germany, U.S. and the union of nations U.K. all have RAs. Each approval was a separate and distinct RA approval.

Beyond approval by multiple RAs, the trial design was approved multiple times by the FDA—the crossover design, for example, was approved twice by FDA because there was a trial halt, and then the trial was approved to resume with the same crossover design it previously had.

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.

https://virtualtrials.org/dcvax.cfm

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

https://nwbio.com/press-releases/

More recent news and events:

https://m.youtube.com/watch?v=h_tev1qm1ZE&feature=youtu.be
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://youtu.be/Oq39FFUwKug
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

Other Relevant Links:

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

https://www.liverpool.ac.uk/systems-molecular-and-integrative-biology/staff/michael-jenkinson/

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

https://connect.uclahealth.org/2021/03/22/ucla-received-590-million-in-nih-funding-second-highest-total-for-academic-medical-centers-in-2020/

https://virtualtrials.org/dcvax.cfm

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

SkyLimit2022

Re: HyGro post# 518555

Sunday, October 02, 2022 10:03:48 PM

Post#
518563
of 518594

Dubious you say? Your postings would be less dubious if you included this disclosure about your investment in NovoCure: