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Re: norisknorewards post# 777982

Friday, 07/25/2025 2:26:33 PM

Friday, July 25, 2025 2:26:33 PM

Post# of 822579
Totally fair, and your analogy is actually a good one. You’re right that unless someone’s inside the MHRA, we can’t know for certain when an internal decision was made. But in your lawncare example, while Company X might not know they were selected yet, if someone called the homeowners association and was told, “We’re just waiting on the homeowner to submit the paperwork,” that would pretty strongly suggest a decision has already been made.

That’s the situation we’re in with NICE. They didn’t say, “We’re waiting on MHRA,” or “The regulator is still reviewing.” They said, “The company is not yet in a position to provide their evidence submission.” Structurally, that suggests the regulator’s role is likely complete, or close to it, and now it’s on NWBO to finalize and submit. That doesn’t prove approval has occurred, but in the context of MHRA’s published process (label finalization, sponsor consultation, press release within 7 days, PAR within 30), it’s a meaningful signal of where we are.

So you’re right, we don’t know the exact internal timing. But based on how these steps normally unfold, and what’s been said publicly, we can make a well-reasoned inference that we’re no longer in the middle of the review. We’re in the final stretch before disclosure.
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