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Re: FeMike post# 777970

Friday, 07/25/2025 2:20:35 PM

Friday, July 25, 2025 2:20:35 PM

Post# of 822846
I appreciate the pushback Mike, and you’re absolutely right to differentiate between quoting and interpreting. Just to be clear: NICE did not say, word-for-word, that they’re “waiting on NWBO.” The actual quote is:

“The company are not yet in a position to provide their evidence submission with us.”

That’s what was said. What I offered was an interpretation of what that line structurally implies, based on how the MHRA–NICE process normally operates.

In NICE’s standard workflow, they don’t begin engagement until MHRA has either granted a marketing authorisation or signaled that one is imminent. If MHRA were still conducting active review, we would expect NICE to reference that. Instead, they shift focus entirely to the company, not to MHRA, not to ongoing regulatory dialogue. That shift doesn’t confirm anything on its own, but it’s a meaningful procedural indicator. It suggests the handoff from regulator to sponsor has likely occurred, placing the next move in NWBO’s hands. That isn’t a fantasy narrative, it’s an inference grounded in the documented structure of how these transitions work.

And while you’re right that “not in a position to submit” could stem from various internal reasons, this is the first time NICE has publicly acknowledged DCVax-L in this context. That alone is new. So yes, it’s possible this reflects a final labeling phase. It’s also possible it reflects internal readiness or coordination. But recognizing the structural pattern here isn’t irresponsible, it’s analytical. This isn’t a declaration of approval, nor is it a direct quote. It’s a reasoned interpretation of where we likely are based on what NICE did, and didn’t say, aligned with MHRA’s published process and timelines.
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