NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Linda Powers: We haven't said anything publicly, so umm, stay tuned! Yes, for everybody else - you're a very well-informed shareholder! - the early access to medicine scheme, the EAM scheme, in the UK, is a two-stage process. So we completed stage-one, and that was the PIM designation. It's very British. Promising Innovative Medicine. That was the intensive evaluation of the technology. And the potential benefits of the technology. And the potential toxicity. The second stage. There's a second stage. And the second stage itself has a couple of stages. First you have to go through a pre-submission process. Make submissions. Get evaluated. And you have to get invited to apply for the second stage. Then you, then you apply for the second stage, and that triggers then a multi-month long further process, which principally focuses on manufacturing. Because is you read the criteria, the decision-criteria, on the MHRA website. MHRA is the regulator agency of the UK, like the FDA of the UK. Umm, the decision-making criteria for stage-one are: Is the disease serious? Are the benefits of this technology potentially a breakthrough? And, is the toxicity worth it? The criteria for the second stage are those same three criteria again; and: how good is your manufacturing? Are we satisfied with your manufacturing? And let me tell you, that for us is, a, a massive sweet-spot. Umm, what we had to go through to satisfy the German regulator to get the Hospital Exemption was very heavily focused on the vigor and quality of our manufacturing. So we've been through that drill and aced it. So we're ready for that.

Conference attendee #5: I have a question about... it pertains to the manufacturing. So let's say, your personalized treatments... what is your capacity? How many of those vaccines, with preparation can you do? And what's your time? (mumbling)

Linda Powers: Yeah. We talk about this. Yeah, we talk about it all the time, because if this technology continues to perform in the way it has been so far and if it's going to applicable to most solid tumor cancers, you're talking about, not 10s of thousands of patients, you're talking of 100s and 100s of thousands of patients for whom it could be a fit. Umm, today the process, umm, the process is to, for the first product, DCVax-L, it's a manual process. For DCVax Direct, it's already partially-automated, the automation system. The answer can only be automation. Right? But, from a business standpoint, there's a point in which the lines cross. Right. We want to get to market and get the product to patients, as quickly as possible. Right, so we're going to do that the way that we're making it now. But, we're busily working, as is anyone who thinks about the future with a cell-therapy product, about end-to-end automation. And one of things about end-to-end automation is, is that it's both a capacity issue, a scale issue, because once you're fully automated in the end, you can virtually treat any number of patients. The other thing is, what people don't often realize is, it's going to further revolutionize your product economics. Why? Because when you make it by hand and there are steps that are open to the air, the whole facility has to be sterile, like a semi-conductor facility. It's massively capital intensive. And that's the biggest part of the finished cost of goods, is those indirect cost of that clean room infrastructure. Once it is automated end-to-end, that all goes out of the equation, because you just have rows and rows of these machines in a warehouse space. So you couple that with the batch manufacturing, and it's a step-change in terms of further enhancement of the economics. And so, everyone is busily working on automation. Umm, we think that's a couple-of-year process from where we are today. And we're working from some of the biggest and the best from all over the world.
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