Totally fair point, and I think you’re raising the right nuance.
Yes, MHRA often defers to the company when it comes to public communication. That’s routine. The agency typically won’t confirm or deny much during an active review and will often say, “it’s up to the company” to disclose what they feel is appropriate. So you’re right, there is some perceived latitude.
But that latitude evaporates quickly once the submission enters its final regulatory corridor, especially under SI 2025 No. 87, which governs patient-specific ATMPs. At that stage, disclosure isn’t just a PR decision, it’s a legal and classification-sensitive decision.
Here’s why that matters:
If the product is misclassified, especially in a public statement, it can trigger a review delay or even force a resubmission.
DCVax-L sits right on the edge of several overlapping categories:
• ATMP
• Cell therapy
• Combination product (if paired with Hiltonol)
• Named-patient special under SI 87
MHRA must get the classification exactly right, because classification dictates:
• Which license pathway applies
• Whether a full MAA is required or not
• Whether the manufacturing site falls under Specials Control Site or traditional CDMO protocols
• What can or cannot be disclosed publicly without compromising the legal basis of the pathway
So if I’m in Powers’ position, sure... I might ask MHRA: “Can we say something?”
But if the answer is vague or negative, even hinting at progress could backfire. One wrong phrase could prompt the agency to pause and re-verify alignment, slowing everything.
That’s the paradox:
The closer you are to the finish line, the more dangerous it becomes to speak freely.
So yes, there’s silence. But from a regulatory standpoint, it’s probably not caution, it’s containment.
And if you happen to have the exact wording of that MHRA email, I’d love to see it. Even subtle phrasing can reveal whether we’re looking at a pre-decision silence, or a structured hold aligned with final activation logic.
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