Replies to post #776869 on NorthWest Biotherapeutics Inc (NWBO)

[seekinganswers]

The entire 10K reads like a Christmas wish list. IMO

"The Flaskworks units will only be usable in the Grade C labs, and hence are not useful until the Grade C labs have been constructed, validated and are operational. Since the timeframe for fabricating the Flaskworks units is much shorter than the timeframe for buildout of the Grade C labs (including the simplified initial Grade C lab), the Company has been holding off on proceeding with the fabrication until closer to the time when the initial Grade C lab will be operational."

Planning, plans, wishing, discussing, preparations, etc...


Intensive activities continued throughout 2024, including in Q4, in multiple areas including the following:


active engagement in the Marketing Authorization Application (MAA) review process and inspections;
planning for possible initial commercialization;
completion, in collaboration with leading clinicians, of the trial design and protocol for the pediatric brain cancer trials to fulfill the legal requirement for ****pediatric applications in connection with the MAA for the adult applications;*****
initial assessments of the specific regulatory requirements for applications for product approval in additional countries beyond the UK;
working with specialized consultants on preparations for reimbursement evaluation processes;
potential expansion of the scope of the Company’s compassionate use program through private clinics;
completion of technology transfer and process development for the DCVax-Direct manufacturing processes to meet UK regulatory requirements (with the DCVax-Direct products able to be supplied globally);
development of streamlined Grade C lab ***plan** for the Sawston facility with faster timeframe and substantially reduced capital cost;
completion of process development for a new and ***potentially enhanced version*** of the DCVax-Direct product;
design of initial DCVax-Direct clinical trials, in collaboration with leading clinicians, and completion of drafting of initial protocols for upcoming IND submissions;
***negotiations*** with multiple independent parties for potential manufacturing in the U.S.;
clinical development activities for initial applications of IP from the portfolio in-licensed from Roswell Park at mid-year;
completion of an upgraded Flaskworks machine for GMP prototypes, and ***plans *** to reduce the dimensions and footprint;

[Slave1]

Jerry,

You posted the 2025 10-K and claimed that because the phrase “Flaskworks EDEN” or “comparability testing” doesn’t appear in that single document, the quotes must have been fabricated. That’s not just incorrect. It’s deliberately misleading.

When someone isolates a silence in one filing and uses it to erase clear disclosures from prior documents, they’re not clarifying, they’re distorting.

Here is what was actually said, and where it was said.


From NWBO’s 2022 10-K, filed with the SEC:

“We are working with Flaskworks to prepare comparability testing and validation protocols for submission to the regulators.”🔗 https://www.sec.gov/Archives/edgar/data/1072379/000141057823000185/nwbo-20221231x10k.htm

This is a direct quote from a federally filed 10-K. It mentions Flaskworks. It mentions comparability testing. It mentions regulatory submission. Nothing fabricated. Nothing paraphrased.


From NWBO’s 2023 Annual Shareholder Meeting:

“Preparations are under way for comparability testing of DCVax products manufactured using the Flaskworks EDEN system.”🔗 https://www.nwbio.com/annual-shareholder-meeting/

This was presented live to investors, supported by images of the EDEN units installed at Advent’s GMP facility, and posted on the company’s official site. It is a formal public disclosure, governed by Regulation FD.

Both statements are clear. Both are verifiable. Both are still part of the public record.

So why didn’t you mention either?

Because the quotes you called fabricated were taken directly from those disclosures. You ignored them, then used one newer filing that didn’t repeat them, and claimed that absence meant they never existed.

But that’s not how SEC reporting works. Companies are not required to reprint operational detail every year unless there’s a material update. Anyone who’s actually read multiple 10-Ks knows that.

You used the absence of repetition to erase documented fact. That’s not due diligence. That’s narrative control.

You pointed to what wasn’t said. I pointed to what was.

That’s the difference.

And that’s exactly what a charlatan does.