I agree that if regulators told NWBO the filing was going to be rejected, even with appeal rights, that would likely need to be disclosed. That would be a materially adverse regulatory development.
The “nothing like that has ever been reported, therefore we are still moving toward approval” argument does not really follow. Silence may be consistent with eventual approval, but it is not evidence of smooth progress toward approval. It is also consistent with unresolved questions, company response delays, manufacturing issues, label scope issues, or other substantive concerns that could still result in rejection.
Trying to get a broader or tumor agnostic label during the initial review could help explain a 2.5 year delay. But that does not make it reassuring. Given NWBO has no commercial revenue and is still funding itself through dilution, shareholders would be justified in asking why management would risk delaying the first commercial approval for a speculative broader label that could be pursued later.
I have to think a variation like that would have required disclosure, or at least would be hard to hide as routine regulatory back and forth. The lack of disclosure suggests this is probably not on the current to do list.
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