Replies to post #800117 on NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

dennisdave,

George Zavoico told me very recently that the approval will be based on the current manual manufacturing process, because that is what is included in the MAA.
He also said NWBio has been working on a closed and more efficient Flaskworks system, but that it must be fully GMP-compliant before it can be used.
According to him, once approval is granted, it becomes much easier to submit an amendment for the new closed manufacturing process.
This aligns with standard post-approval variation procedures for ATMPs."

[QL300]

This manufacturing process needs to validated as part of the MAA. Multiple regulations require this. The PR says "large scale up of production" not that this is required for approval. Before you say I'm wrong, read below. If I am wrong, cite evidence that contradicts what is found on the MHRA's website. 
The MHRA conducts product-related inspections when assessing an application for a UK https://www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk. This inspection checks if the manufacturer complies with . We tell you about this inspection in advance.During an inspection the inspection team will:Site visits may include any facility or process involved in producing, purchasing and distributing medicines, including:Here is the link:https://www.gov.uk/guidance/good-manufacturing-practice-and-good-distribution-practice

[barnstormer]

DD, I wasn't trying to take sides. Took no exception to what you had said in prior posts. My position was that adding Flaskworks to the MA in midstream adding six months to possibly a year or longer to the MA process was significant enough to require notifying shareholders of the change. I take exception. significant enough to meet the requirement. Your own statements from your last posts confirm that the addition of Flaskworks will likely add up to a year to the process. You can quote CMC requirements, but NWBO is still a US company subject to SEC regulations and the right thing to do was notify shareholders of the change. I was only offering my opinion that notification should have been done.

"If manual Grade B were the intended commercial process, MHRA could have approved months ago.
Manual is already fully licensed, inspected, validated, and used for Specials. There is nothing left to review."

"The process is completed once the Grade C suite is finished and validated, which is expected by mid next year if you actually read NWBO's last PR"

"The Typical timeline would be 6 months extra counted after the regular 210 clock on days have passed (depending on the readiness of the facility (Grade C suite and the MHRA inspections of Flaskworks). My best estimate: end Q1 2026, assuming the validation of the first Grade C suite completes early next year."

[barnstormer]

DD, I have no argument with part 1, A thru C, part 2. On 3, I don't think we'll know if the CMC update adds a year or more until construction is completed and approved, equipment is installed, tested and approved. My experience with construction is that it normally takes longer than originally estimated.
My position is when Flaskworks was added, shareholders should have been notified either by PR of 8-K. I assume we can agree that the MAA was submitted Dec 21,2023, receipt acknowledged by the MHRA on Jan 24, 2024, and validated on March 7th. You've referenced Nov 20,2025 PR in support of your position. I'll call and offer the Feb 6, 2024 PR supporting mine. From that PR:

"Next Steps
The next step is to have GMP-compliant (i.e., clinical grade) versions of the prototype Flaskworks machine made with GMP grade materials. A specialized contractor has been engaged to do so. This process is expected to take several months, in part due to ongoing supply chain issues. As soon as the GMP-grade units are delivered, Advent BioServices will undertake final qualification and validation of the GMP units and use engineering runs with the system to collect data in order to submit an application to regulators to approve the use of the system for production of DCVax-L for patients.
The Company is optimistic about this approach because the Flaskworks system now closely mirrors the existing manufacturing process, and the DCVax-L products manufactured through the Flaskworks system are substantially comparable to the DCVax-L products made through the existing manual process."

It's evident the system wasn't near ready to be added at that time. When was it added is the question. I'll guess we'll know someday. But back to the question at hand. Your position is the CMC rule applies and no notification of the Flaskworks addition was required. Mine is the addition was significant enough to impact investors actions had it been known and SEC Regulation FD applies.
I don't believe either of us is likely to change our position, so let's just agree to disagree and let it go.