Tuesday, August 12, 2025 7:44:21 PM
Exactly, we can talk openly about what’s already in the public domain and connect the dots based on the regulatory process and past precedent. The company is bound by strict disclosure rules and confidentiality obligations while the MHRA review is underway. They cannot selectively comment on specific points without risking a breach of regulator requirements or market disclosure laws. This includes anything that could be considered “inside information” under UK Market Abuse Regulation until it’s formally announced.
That’s why it’s important for shareholders to keep the conversation factual, sourced, and grounded in how the process actually works. If we don’t, the vacuum gets filled with speculation, fear, and doubt from those who either don’t understand the process or want to distort it.
The FOI reply, the NICE letter, and the CHM’s role are all examples of public, verifiable information that, when read together, point to the same stage, finalising the SmPC, or “labeling.” This is one of the last steps before MHRA issues the licence. We can talk about that all day, because we’re drawing from what’s already public and explaining the sequence.
The company can’t say “we’re in labeling” without making an official disclosure, but we can explain why the public record fits that description. In that way, we fill the gap with informed, evidence-based discussion instead of letting FUD fill the void.
That’s why it’s important for shareholders to keep the conversation factual, sourced, and grounded in how the process actually works. If we don’t, the vacuum gets filled with speculation, fear, and doubt from those who either don’t understand the process or want to distort it.
The FOI reply, the NICE letter, and the CHM’s role are all examples of public, verifiable information that, when read together, point to the same stage, finalising the SmPC, or “labeling.” This is one of the last steps before MHRA issues the licence. We can talk about that all day, because we’re drawing from what’s already public and explaining the sequence.
The company can’t say “we’re in labeling” without making an official disclosure, but we can explain why the public record fits that description. In that way, we fill the gap with informed, evidence-based discussion instead of letting FUD fill the void.
Bullish
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