Replies to post #799171 on NorthWest Biotherapeutics Inc (NWBO)

[Slave1]

The key point is that SOW-8 and the new Grade C manufacturing suite are about two completely different things, and they occur on two different regulatory timelines. SOW-8 was carried out in Sawston using the existing Grade C cleanrooms that were already real, licensed, ISO-qualified, and functional well before 2024. That is documented in three independent places: the Catapult manufacturing surveys (showing 3 Grade C rooms as far back as 2023), the 2023 10-Q (Phase 1B completion with new PD lab + multiple Grade C rooms), and the SOW-8 milestone disclosures themselves (APS, PPQ, equipment qualification, all of which are legally impossible without functioning Grade C/B/A space). So yes, Sawston already has Grade C rooms and they were absolutely functioning for SOW-8.

The November PR is not announcing the first Grade C capability. It is announcing the first Grade C manufacturing suite dedicated to Eden, which is a commercial-throughput, multi-pod, high-volume block designed for scale-out? not basic regulatory readiness. NWBO is building it now because Eden is close to regulatory comparability and because they expect commercial demand. You do not wait for the next 10-Q to announce a major construction project that more than doubles capacity; you disclose it immediately, just like they did with Phase 1A and 1B. It is a sign of expansion, not a sign of missing infrastructure.

So to your concern: No, this does not delay approval. The existing, licensed Grade C cleanrooms are already operational and were already used for SOW-8, which is the regulatory prerequisite for DCVax manufacturing readiness. The new suite is simply a larger, Eden-optimized commercial unit that will take throughput from “functional” to “high-capacity.” It’s the difference between “we can manufacture” and “we can manufacture at scale.” The PR is about the latter, not the former, and it does not imply that NWBO must wait six months for a Grade C environment to exist. It already exists.

Finally, Beartrap is correct: the Catapult 2023 report confirms that Advent already had 3 Grade C cleanrooms inside Phase 1B years ago. That matches all the independent documentation, and fully explains how SOW-8 was completed at Sawston.

[beartrap12]

Meirluc, Just to clarify, those 3 Grade-C cleanrooms were completed in 2023, and were (still are) licensed cleanrooms,according to the 2023 Catapult Report that reports on the availability of cleanrooms across the UK. They were used for improving and testing and qualifying (right word?) the EDEN unit before it was determined ready for manufacturing. Also, remember in the last two years they created a second EDEN unit, which I suspect may become EDEN 2.0 (though the company said it was too large and went back to the first model. Covering by company just in case? The newest patent certainly sounds like the EDEN we're not using yet!)
It appears that that group of 3 Cs in the B1 suite might continue to be used to advance the EDEN, according to language in the 10Q 2023, though that is also a bit of an assumption on my part because the company could chose to re-house it some place else.
Have a good weekend, all longs.