Saturday, November 29, 2025 1:20:52 PM
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.
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.
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