NorthWest Biotherapeutics Inc (NWBO)

[Slave1]

Thank you, I really appreciate that. Point blank, I think the delay is strategic. Everything on the regulatory and manufacturing side appears to be done. The MHRA already approved the Pediatric Investigation Plan using the same trial design and external controls. Advent is fully licensed and has been producing the clinical and Specials batches out of their GMP facility. Flaskworks is not part of the current process. It’s still in validation and not being used yet.


So what’s holding it up?


I think this is about timing and positioning. The MHRA has spent the last couple years redefining how it handles real world data, external controls, decentralized trials, and post Brexit innovation policy. DCVax-L checks every one of those boxes. This isn’t just a product approval. It’s a model shift. And when a regulator uses a product like this to make a statement, they time it.


Could it also involve coordination with other agencies? Possibly. Project Orbis isn’t formally involved, but the same kind of synchronized logic applies. You don’t want to greenlight something disruptive like this in isolation. You want to align it with the broader ecosystem. That takes planning, even if the core review is already done.


And yes, there may be some quiet pressure behind the scenes. A therapy like this threatens more than just one drug. It threatens the status quo. That alone is enough to slow a system down, even if no one openly admits it.


If this were a rejection or a deficiency, we would have seen it reflected by now. In filings, in tone, in regulatory notices. We haven’t. The silence doesn’t feel like failure. It feels like something being managed carefully.


So no, I don’t think this is about missing data or manufacturing gaps or Flaskworks delays. I think it’s about controlling the moment. And when the moment is right, it will move fast.