NorthWest Biotherapeutics Inc (NWBO)

[Slave1]

Fair point, but it misunderstands the structure the analogy was meant to illustrate. It’s not about comparing a university exam to a fixed regulatory deadline. It’s about the sequence of responsibility: who holds the process at each stage, and what that implies procedurally.

Yes, RFIs are a standard part of the MHRA review. But once the agency finishes its evaluation and issues a positive internal opinion, the next phase is labeling, just like preparing a diploma after a student has been cleared to graduate. At that point, the process shifts from the regulator to the company.

That’s exactly what the NICE letter reflects. It doesn’t say MHRA is still reviewing. It says:
“The company are not yet in a position to provide their evidence submission with us.”
That means NICE is waiting on NWBO, not the regulator. And by NICE protocol, they don’t expect that submission until MHRA has handed off a decision. So if NWBO is holding the next move, it strongly suggests we’re past the review phase and into finalization, most likely labeling.

Could there have been RFIs? Possibly. But if that were the case, the delay would sit with the regulator, not the company. That’s not what the letter says. The silence here doesn’t signal failure or success, it signals a handoff in progress. And that’s exactly what the analogy was meant to highlight.