Replies to post #558666 on NorthWest Biotherapeutics Inc (NWBO)

[Dr Bala]

Thanks for the post, HyGro.

[hoffmann6383]

The first sentence is repeated fabricated bullshit. I didn't read further.

[SkyLimit2022]

Thanks for reposting your views again.

I think you’re highlighting a lot of the confusion, misinformation, and disinformation that stock shorts exploit to muddy the waters.

The trial had changed over time because patients lived long and it spanned many years. The SAP 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

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.

Verify facts. Seek truth and credible sources.

[dstock07734]

No real investors in NWBO would believe these fabrications.

Did you see CEO, chief science officer, and chief development officer from NVCR dump their shares at peak four days before the 4th quarter report out which listed only 10 new patients recruited last quarter? They know better about the NVCR's destiny.

[biosectinvestor]

I addressed this yesterday, in this post where I discuss that they were working with the 4 Regulatory Authorities on this for a few years before.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=170913553

[Roman516]

But yet, NWBO's trial data TLD passed the OS is outstanding and that is the fact of the matter.
But yet, the statistical end points are just that they were just statistical guesses.
But yet, JAMA agree to publish the data based on their team and review processes.

[CherryTree1]

This is complete bullshit

the protocol, the endpoints, the comparators and the SAP. All the trial had been complete. It is unheard of

I guess you didn't read my post on this from October
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=170236939

The protocol NWBO is following has been standard practice for some time. Here is information from 2010
http://onbiostatistics.blogspot.com/2010/04/when-to-finalize-statistical-analysis.html

When to Finalize the Statistical Analysis Plan (SAP)?
"The statistical analysis plan may be written as a separate document to be completed after finalising the protocol. In this document, a more technical and detailed elaboration of the principal features stated in the protocol may be included. The plan may include detailed procedures for executing the statistical analysis of the primary and secondary variables and other data. The plan should be reviewed and possibly updated as a result of the blind review of the data (see 7.1 for definition) and should be finalised before breaking the blind. Formal records should be kept of when the statistical analysis plan was finalised as well as when the blind was subsequently broken.
If the blind review suggests changes to the principal features stated in the protocol, these should be documented in a protocol amendment. Otherwise, it will suffice to update the statistical analysis plan with the considerations suggested from the blind review. Only results from analyses envisaged in the protocol (including amendments) can be regarded as confirmatory."
This indicated that the ICH principal is followed as long as the statistical analysis plan is finalized or signed off prior to the study unblinding (or database lock if it is open label study). I believe this is the common practice in industry.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines.