NorthWest Biotherapeutics Inc (NWBO)

[Slave1]

You’re right Senti, and I’ll own it. When I mentioned August 2, 2025 as Day 210, that was a mistake. That date was based on the 2024 MHRA procedural calendar, and I should have made that clearer. The correct Day 210 under MHRA’s accelerated review would’ve been August 2, 2024, if no clock stop had occurred.

So yes, I overlooked that, and that part’s on me.

But here’s what matters: even with that correction, all the structural facts still hold, and nothing materially changes in terms of where we are in the process.
Let’s walk through it:

1. The 10-K (Filed March 31, 2025)
NWBO explicitly confirms the DCVax-L application is under the MHRA’s 150-day accelerated review pathway, which by definition includes a possible clock stop after Day 90. That allows the process to extend beyond the standard 210 days without breaking protocol.

2. MHRA Guidelines

Under standard MHRA procedure:

• Day 0 = Jan 5, 2024
• Day 90 = Apr 4
• Day 150 = Jun 3
• Day 210 = Aug 2

If a clock stop was triggered, which is both common and allowed under this pathway, then the calendar would pause, potentially for months, until NWBO’s response was received and accepted. That would explain why we are now in late July 2025 and still awaiting the decision.

3. ASM (June 29, 2024)
At the Annual Shareholder Meeting, NWBO laid out the three-phase structure of the review:

1. Initial evaluation
2. Clock stop (RFI)
3. Final assessment

They stated directly: no interim updates, only final outcome. That’s aligned with MHRA policy and with how similar ATMP reviews have been handled.

4. SI 2025 No. 87

SI 87 became law on July 23, 2025, literally two days ago. This is not speculation. It enables named-patient access under UK “Specials” for licensed ATMPs like DCVax-L. It’s a regulatory deployment channel, not a review signal, but it’s a major piece of infrastructure now in place.

Final Clarification

Yes, I overlooked the year shift on the Day 210 anchor. But the guidelines haven’t changed. The 10-K still stands. The ASM remains consistent. The NICE letter Flipper received is still valid. Labeling is likely underway, and today marks the last CHM meeting before August.

So at this point, the debate is mostly a mental exercise. Whether you anchor to August 2024 or count forward through a paused clock in 2025, all signals converge in the same place:

The review is still active.The silence is intentional.The infrastructure is now in place.

We are not out of window. We are at the edge of it.
Stay steady.