Replies to post #765649 on NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

The Follower,

Correct! what I refer to is perhaps mischaracterized by me at times. My reference is supposed to be only to the post installment engineering runs and validation. This will take less time than some of the more vociferous negative posters presume to assume with authority; ). While that is happening the first Grade C clean room space will likely be used for the pediatric trial and Specials once there is an approval. Best wishes.

[biosectinvestor]

I agree. I believe they are working likely to validate with as close to approval as possible. That is usually the most optimal time. A lot of these newer drugs are made by hand in labs for the early trials. Creating a full, automated, commercial facility long before a product is even applied for for approval, is the road to technological death for the most innovative and small bios with the newest ideas and technologies. Of course for Big Pharma, they can do whatever they want. But the FDA killed many early, small bios, decades ago, by forcing them to have full, commercial operations BEFORE their trials even started, at the beginning of this technology. They thought, the end product, in order to be validated, had to be made in the EXACT conditions of a full factory for commercial production, to validate from Phase 1. They killed off many companies and prevented much research. They just did not know any better. They had a hand on the science, but failed to grasp the commercial impossibility they were creating. So it is expected that manufacturing will be part of that process and scale up into the approval and after the approval process, and that's why it happens best at this time, not before, not earlier, because then you have a fallow factory, that you have to maintain in pristine shape and ready to go, when you're not producing any product and there is zero revenue. That is very costly. But the shorts would have you believe that they haven't even started or thought of it yet. The cost for the new clean rooms is lower. The tech is more cost efficient. It has not been some prohibitive, massive investment of billions of dollars to get to this stage and the shorts would of course, speculatively lay it all on thick, make comparisons with other technologies without any thoughtful comparison, and make people fear. Now, that's not to say that market forces will immediately change, or that they won't need to raise funds to scale up if no deal materializes to make it much easier. But the fact is, the shorts know far less than they think they do and they make their money by always predicting the worst, worst case and making it seem as if it is the most likely and most practical reality. That's easy money for them.

Great post TheFollower.

[exwannabe]

I believe the testing has been done and validated by the regulators prior to the new Flaskworks patent just issued.

NWBO stated clearly in the 10K that delivery of the EDEN units that will be tested is on hold until the class C cleanroom is operational. Kind of hard to test something before one has it.

During 2024, the Company’s Flaskworks subsidiary and a specialized contractor developed a GMP-compatible prototype of the Flaskworks system for a “closed” manufacturing process for DCVax-L. Another prototype, with smaller dimensions, had been developed in 2023. The Company has determined that the smaller prototype will be preferable, to enable more units to fit in each manufacturing lab. Production of the GMP-grade units will be timed to coincide with the timing for buildout of Grade C labs in the Sawston facility. When the GMP-grade units are delivered, Advent BioServices will undertake qualification and validation of those units, conduct engineering runs and collect data, and apply to regulators for approval to use the system to produce DCVax-L for patients. As previously reported, the Company views the Flaskworks program and system as a centerpiece of efforts toward scale-up for potential commercial operations.

But I see biosec agreed with your BS pump. So I guess the 10-K was wrong.

[DJPele]

This is wrong.

The GMP units won't even be in production until NWBO starts the build out for the Grade C labs. Only then will qualification and validation occur, AND ONLY THEN will they submit to the regulators.

From the 10K:

Production of the GMP-grade units will be timed to coincide with the timing for buildout of Grade C labs in the Sawston facility. When the GMP-grade units are delivered, Advent BioServices will undertake qualification and validation of those units, conduct engineering runs and collect data, and apply to regulators for approval to use the system to produce DCVax-L for patients.

Again, from the 10K regarding the Grade C Labs:

Simplified Grade C Lab in the Sawston Facility. The Sawston facility current has two Grade B labs. Such labs are required to be used for any manufacturing process that involves any open steps (i.e., open to the air). Grade C labs are much less expensive to operate, and allow multiple patients’ products to be manufactured at the same time in the same lab, but may only be used with closed systems. The Flaskworks system is closed and suitable for Grade C labs. The design and engineering works were previously completed for two Grade C labs, but the buildout will require substantial capital. Since the Company believes it will have adequate capacity for initial possible commercialization with the two Grade B labs, the Company has held off on raising and using the capital required to build the two Grade C labs. Meanwhile, Advent has devised plans for a simplified initial Grade C lab adjacent to one of the Grade B labs, making use of existing shell space and drawing upon some of the infrastructure associated with the Grade B lab. The simplified Grade C lab can be completed for a fraction of the cost and less than half the time for the regular Grade C labs. The Company anticipates potentially proceeding with this in the coming months when appropriate.

I feel like I am talking to a brick wall about this specific issue.

Since the Company believes it will have adequate capacity for initial possible commercialization with the two Grade B labs...

They are already planning to move forward with commercialization using the Grade B labs. It's plain as day that Flaskworks won't be verified or approved by the time we get approval.