Replies to post #520711 on NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

Thanks for posting, but you’re thinking of Optune and NVCR I think. NVCR has a very dubious business outlook and future. Look at all the serious risks that they have buried in their SEC filing… it is no wonder that the share holders are heading for the exits. Novocure is down to A THIRD of its share price since the peak just one year ago in June when it was over $200.

Look at all risks buried in their SEC filing on pages 25-51 of the document linked below. They have 26 pages of product efficacy risks, regulatory risks, legal risks, financial risks, market competition risks… etc etc. They admit under penalty of perjury that their company has serious risks.

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

[SkyLimit2022]

Yes, thank you—you are correct to point out that there is a lot of disinformation about the trial, and people need to independently verify the facts for themselves.

The landmark trial was a brilliant success and the independent peer review is forthcoming.

OS is the gold standard.

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. OS naturally became a “hard endpoint” for the P3 as the trial spanned so many years.

“OS is the "gold standard" for measuring the clinical benefits of a cancer drug. The global trial has also reached the secondary endpoint of OS in recurrent GBM with statistical significance.”

“The ultimate goal of all oncology drugs is to improve patient-centered endpoints. These 'hard' endpoints, which are intrinsically valuable to patients, are increased overall survival (OS), improved quality of life (QoL), or both. However, by many drugs are approved or used based solely on their ability to improve surrogate endpoints; outcomes that are not inherently meaningful, but aim to predict hard outcomes.”

“In oncology, the most commonly used surrogates are response rate; a set of criteria characterizing tumor shrinkage; and time to event endpoints, such as progression-free survival (PFS)”

Overall survival is the gold standard and remains the definitive end point in cancer clinical trials.

Quite simply:

You cannot mistake
the dead for the living.
That is why OS is the
gold standard.

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

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

[AAPL31415926]

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[Roman516]

We all know why NW stock was hammered after 5/10/22. The good news is that the OS data was presented well, and it we well received and many doctors, scientist and professionals who all agree.
Manufacturing, manufacturing is the key factor to receive qualifications for a GMP and followed by the MIA/MA. The good news is that NWBO and its manufacturing partners are focusing on advanced automated manufacturing process which the Regulators respect and encourage prior to their approvals. Most investors do not have the technical insights regarding manufacturing process and the importance it has regarding regulatory approvals.
Fortunately, there are a handful of individuals who strive to help investors understand the details and help inform them accordingly.
Looking forward to approvals based on the fact that the OS data is in fact valid and will help both nGBM and rGBM brain cancer patients soon.