NorthWest Biotherapeutics Inc (NWBO)

[Slave1]

Actually, that’s not correct, and it’s important to understand why.

If NWBO were to issue a PR before the final SmPC is agreed upon with the MHRA, and if that PR mischaracterizes the status of the labeling process, it would directly violate both regulatory expectations and the principle of “no preapproval promotion.” That could jeopardize the approval timeline or trigger a formal delay while the regulator investigates potential misrepresentation.

Why?

Because in the UK’s regulatory framework, especially under SI 87 and the ATMP (Advanced Therapy Medicinal Product) pathway, the Summary of Product Characteristics (SmPC) is not a footnote. It’s the central legal document that defines:

• What the therapy can treat
• Which patients are eligible
• What the product is, legally speaking

Until the SmPC is finalized and accepted by the MHRA, the product doesn’t yet have defined legal status as an approved medicinal product. It’s still in regulatory limbo. If NWBO issues a PR stating or even implying approval while the SmPC is still under negotiation, it would be seen as jumping the gun, a breach of trust in a tightly regulated process.

Regarding the 10M dilution:

That’s unfortunate, yes. But the correct framing isn’t “why didn’t they issue a PR?” The right question is: Would issuing a PR right now help or hurt? And the answer is: It could hurt. A premature or imprecise PR could create more damage than silence if it results in a regulatory freeze or legal friction at the labeling stage.

We’re not in the waiting room for a marketing campaign. We’re in the final phase of a legal classification process.

And once the SmPC is finalized and approval is official, then a PR becomes not only safe but required.