Thanks, Gary. I think you’re asking a question that sits at the heart of where we are right now, and it deserves a complete response.
It’s entirely possible the company initially pushed for broader language, maybe even something that edged toward tumor agnostic, and then adjusted based on the regulator’s response. That’s how these negotiations often play out. A sponsor submits a draft label with supporting rationale, and then the regulator narrows or redefines it to fit their comfort zone. When you’re dealing with a novel platform like this, the cleanest path to first approval is usually the one that stays tightly linked to the trial data. If that means starting with GBM alone, I think it’s the right move.
Whether they submitted compiled anecdotal or IFR data in support of a broader claim is harder to answer. We haven’t seen that data publicly, and probably never will. But that doesn’t mean it was never shared. There’s a difference between public disclosure and what is provided confidentially to regulators as part of label negotiation or post-submission dialogue. I’d be surprised if the company didn’t at least reference patient-level outcomes from IFR and Specials use in some capacity. It might not have been framed as a formal expansion argument, but it could still reinforce the system’s safety, consistency, and durability.
At this point, if they are pursuing the surest path, it makes sense to stick to the narrowest viable label. That gets the infrastructure legally activated. And once you have lawful approval, everything else becomes modular, via off-label use, IFR continuation, SAP in Canada, ATP expansion, or future label revisions.
Personally, I would be happy either way. The goal has always been to get this across the line, and if that means starting with GBM and scaling outward, so be it. The real story is not the first sentence in the label. It’s the architecture behind it. The product works. The platform is validated. The biology is strong. The regulators are engaging. And the infrastructure to deliver this globally is already wired.
Approval means the framework is real. It means the delivery model, the GMP systems, the clinical safety, and the legal traceability have all been accepted. That puts NWBO in a completely different position, not just clinically, but strategically.
And yes, that includes the legal case. Approval changes the risk profile overnight. The company would no longer be a small biotech claiming harm. They would be the owners of a licensed immunotherapy platform with institutional capital flowing in. That could shift the calculus entirely. At that point, they may decide they are better off going to trial with public credibility, revenue momentum, and a global deployment strategy at their back.
In that kind of environment, settlement becomes optional, not necessary. And if they feel they can win, legally and reputationally, they may not want to give anyone a discount.
So yes, I think we’re close. Whether the label says GBM or more than that, it’s going to mark the start of something bigger. They may end up changing not just how we treat solid tumors, but how we hold the system accountable for trying to keep that change out of reach.
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