NorthWest Biotherapeutics Inc (NWBO)

[Slave1]

I understand where you’re coming from, but based on the structure of the NICE letter and the MHRA’s official guidance, there’s good reason to lean toward interpretation #1, that internal approval has likely already occurred, and we’re now in the final documentation phase. The NICE quote, “the company are not yet in a position to provide their evidence submission with us,” is key. NICE doesn’t open its process until MHRA has finished theirs. The fact that NICE isn’t referencing ongoing review or regulator coordination, but is instead pointing directly to NWBO, suggests the ball has already shifted to the company. That handoff doesn’t happen before approval.

According to MHRA’s own published process, once a product is approved, the agency collaborates with the company to finalize the Public Assessment Report (PAR), the label (SmPC), and other supporting documents. For new active substances like DCVax-L, the MHRA aims to publish a press release within 7 days of authorisation, and the PAR within 30 to 60 days, depending on classification. During that window, the company reviews the final text and confirms all redactions and formatting. It’s a quiet but critical part of the regulatory timeline, and that silence is expected, not unusual.

So if MHRA granted internal approval in late June or early July, which is consistent with the NICE letter dated July 15, then we are now well within the post-approval finalization window. That means a public announcement, whether it’s a press release or a published PAR, is structurally expected anytime between now and mid to late August. The exact timing depends on how quickly NWBO and the MHRA complete the final document coordination. In short: this isn’t the beginning of a delay, it’s the end of a process. Everything points to approval already being granted behind the scenes. What remains is formatting, confirmation, and publication. We’re not early. We’re close.


✅ Conclusion:

With today being July 25, and considering the July 15 NICE letter already places the next move in NWBO’s hands, we are very likely within the post-approval finalization window defined by MHRA protocol.

That means:

📢 A public announcement (press release and/or PAR) is structurally expected anytime between now and mid-to-late August, with the exact date depending on how quickly the company and MHRA finalize the last-stage documents.