That is not how materiality works. Materiality is not limited to final official events. It depends on whether a reasonable investor would consider the information important. The Supreme Court’s Basic v. Levinson analysis specifically rejected the idea that only final, certain events can be material. Preliminary merger talks, for example, can be material depending on probability and magnitude. The SEC also describes materiality as information a reasonable person would consider important.
I am not saying every regulatory communication has to be disclosed. Routine back and forth with regulators, labeling discussions, CMC questions, manufacturing comments, or review issues may not be material by themselves.
But look at the case being made here. The argument is that NWBO is cash strapped, so management would not take on expensive tech transfer, leukapheresis expansion, manufacturing buildout, staffing, validation work, and facility commitments unless they were highly confident approval is coming.
I understand the argument. But that still does not prove MHRA has given a positive approval signal.
A cash strapped company can still make expensive moves if the alternative is worse. NWBO has one main path: get DCVax-L approved and make the commercial manufacturing process credible. If leukapheresis, manufacturing readiness, QA systems, validation, tech transfer, and capacity planning are prerequisites for approval, then spending on them may not be optional. They may not be spending because approval is assured. They may be spending because without that spending, approval is impossible.
So the question remains: what is the claimed confidence based on?
If it is management’s own judgment that approval is possible, then the activity shows confidence and preparation, not regulatory certainty.
If it is based on specific positive feedback from MHRA, then what exactly did NWBO learn that justified taking on those financial burdens? If the feedback is strong enough to support the claim that approval is close, then it starts to sound material. If it is too vague or preliminary to be material, then it is also too weak to support the claim that approval is effectively on the way.
That is the gap. Expanded spending may show preparation. It may show urgency. It may show NWBO is trying to satisfy unresolved prerequisites. But it does not automatically prove positive MHRA intent or that approval is already effectively known.
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