NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

Flipper today

It’s remarkable, curious and telling that the entire NWBO ihub board are not putting this together.

1. After several years, the German European DCVax-l clinicaltrials site awakening from hibernation in late August 2025 to note international data/trial completion occurred back on December 31, 2024.

2. That clinical trial site utilizes essentially the same endpoints as the DCVax-l SAP in the JAMA article.

3. The American clinicaltrials.gov site previously limited itself to only two endpoints. The ones we’ve seen thus far,

4. At least two of the endpoint results not released yet would benefit from the time that we’ve collectively endured (investors, patients, etc).

5. It’s been nearly ten months since the international trial completion occurred. If the additional data was folded into the MAA as supplemental data, perhaps in the spring, that would be an anticipated/expected development by the parties ultimately requiring full use of three RFIs, before and after data may have been submitted.

6. MHRA seemed to suggest to Lykiri there was another CHM look at DCVax-l around the end of May or June.

Then get out of your isolated ecochamber Flipper and start the conversation here. Anyway:

Yes its wonderful and great that NWBO submitted the additional dataset to MHRA.
But what’s even more interesting is that this move also looks like NWBO is preparing to submit to the EMA. Here’s why:

* The German EU clinicaltrials registry was just updated after years of silence, formally declaring the global end-of-trial date as December 31, 2024.
* That “global” language matters it’s exactly what you need if you plan to use the data for an EMA MAA or conditional approval.
* The EU registry now lists the full set of endpoints consistent with the JAMA SAP, not just the limited endpoints we saw on clinicaltrials.gov. That means the data package is EMA-ready, not just UK-ready.
* If NWBO was only focused on MHRA, they wouldn’t need to wake up the EU trial registry after all these years.

This is how you build a global regulatory strategy: first secure UK approval, then quickly follow with EMA submission right after that.