Replies to post #782009 on NorthWest Biotherapeutics Inc (NWBO)

[seekinganswers]

Conclusion
This dendritic vaccine trial has several limitations. These limitations include changing the primary endpoint (OS instead of PFS), creating a new study population (recurrent glioblastoma), conducting unplanned analyses, using external controls in a design originally intended to be randomized, all changes occurring years after the trial finished enrollment. The selected external controls likely included patients with less favorable outcomes, which opposes the “fit-for-purpose” criteria usually applied in selecting external controls. Therefore, the purported survival benefit from the vaccine is unreliable. The accumulation of limitations, along with multiple changes made over nearly two decades; further hamper the reliability of the reported results. Without data sharing, those concerns cannot be alleviated. Glioblastoma is the most common primary brain tumor, and there is no valid reason to stray from the gold standard of a randomized-controlled trial with overall survival as the primary endpoint in order to change clinical practice. Dendritic cell vaccination is a very promising approach for GBM, the neuro-oncology medical community can only regret that due to the described DCVax-L trial weaknesses, we cannot draw any conclusions on potential efficacy.
https://www.sciencedirect.com/science/article/pii/S0035378723009190?via%3Dihu

PS....
"The Pediatric Investigation Plan (PIP)
Critically, this guidance builds upon existing regulatory precedent. In June 2022—well before the 2025 guideline—the MHRA approved NWBO’s Pediatric Investigation Plan (PIP) for DCVax-L."

That PIP trial design was rejected by field clinicians and is apparently being re written by NWBO,... No confirmation of the new trial design has been presented by NWBO , to date.

Stop posting lies!

[seekinganswers]

Thanks for responding.
I guess those are all the reasons why the stock is down 99.99 % since IPO, there are 2 Billion shares outstanding, (fully diluted) at $0.24 cents per share, almost no cash on hand, no approval after 7 years, and nothing more than dilution, extended losses, plans for a new and improved DCVax, huge salaries, and plans for new trials for the new super duper turbo booster version of DCVax in Q2,3, 4, etc. ???
Cool story Bro.

[seekinganswers]

Is it "due course" yet???? LOL 🤣. SEC filings are a funny thing... NOTE: "Substantial Changes"

"In 2024, NWBO engaged pediatric neurosurgeons and oncologists who requested substantial changes to the design of the planned pediatric trials. A new pediatric trial protocol was agreed upon with these clinicians, and NWBO plans to submit this protocol to the MHRA for approval "in due course."

[manibiotech]

Thanks DD
I have posted in the past also about these BS narratives about cherry picking ECA patients . I will post with excerpts and links this time so it can be put to rest . ECA protocol was established independently by consulting firm YHEC ( York Health Economics Consortium ) with no involvement of NWBO:

From JAMA paper here

“ External Control Populations
The ECPs were determined by an independent expert firm (York Health Economics Consortium) and comprised patients from the control groups from contemporaneous RCTs closely matched to the current study based on 14 criteria prespecified in the SAP (Supplement 1). These studies met the “fit for purpose” criteria outlined by Mishra-Kalyani et al.8 We compared the treatment groups of the external trials to the ECPs to validate the methodology, applied sensitivity analyses to check for biases, and conducted a matching-adjusted indirect comparison (MAIC)18 to adjust for imbalances in individual patient characteristics”
“ the MAIC analysis applied here is a powerful method to overcome the lack of such individual patient data and to enable matching of specific patient characteristics in external controls compared with patients in the investigational group. This method also has wider general applicability to provide reliable comparative evidence of benefit”

From NWBO’s slide from Slide deck (GBM Drug Development Summit, Mar 15, 2023): slide 15

“ External Controls (ECP)
Criteria used to identify the trials included the following:
• Randomized controlled trials
• Control arm with SOC or physician’s choice
• Patients must be 18 years or older
• Contemporaneous with DCVax-L
• KM plots for OS (and subgroups) included for digitization
? Independent expert firm evaluated & selected the comparators with
no Sponsor involvement”

https://nwbio.com/wp-content/uploads/NWBT-GBM-Summit-slides-3-15-23.pdf

Here is the consulting firm used

https://yhec.co.uk/yhecservice_type/full-submission-support-pharma/

The firm provides services to NICE and NHS along with Pharmaceutical companies and other industries

https://yhec.co.uk/client/national-organisations/

[RRP60]

Amazing, amazing reply DD. Thanks for putting out the compilation of actual facts so quickly. Very nicely done. If the negative nellies stick to the same nonsense after reading this, it tells me they are blind, deaf and thickheaded. This write up need to be stickied for new investors to understand the longs reasons to have conviction in this investment. To me this is as truthful as it can get . Iam not talking about regulatory decision, it can go any way but the above points from DD will hint at imminent approval in due course.why are you guys so afraid of DD and start trashing him as a paid pumper. He has a great talent to write about what he sees in this stock. Thats not pumping, he is a legitimate investor and owning stock here. On the other hand  the negative group are non stock owning good hearted activits. You make your assumption.  World is not blind to see the difference. peace. 

[sukus]

Amazing rebuttal.