NorthWest Biotherapeutics Inc (NWBO)

[GoodGuyBill]

Gary, you may be on to something, regarding

Of course, I'll continue to look at the possibility that this isn't a UK decision at all, that secretly it's been done under Orbis and that four different regulators are working together on the approval. It would be a huge positive, but clearly if true, it would explain why it's taking so long.

If this were purely a UK regulatory process, why would NWBO be actively building U.S. manufacturing infrastructure for in-licensed technologies—before any public FDA submission (according to the recent 10Q)?

The Company continued its progress on developing manufacturing capacity in the US for technologies that the Company has in-licensed…selected two locations… progressed with contract negotiations… secured initial key anchor personnel… negotiating with key equipment suppliers.

Meanwhile, Sawston is already handling DCVax-L and DCVax-Direct “for global use.”

So why the parallel buildout? Either NWBO is preparing for future demand post-approval, or—as you suggest—there’s a coordinated regulatory pathway already in motion, possibly under Orbis. That would explain both the silence and the infrastructure.

Companies don’t spend millions on GMP buildouts without strategic alignment. If this were just “hope,” it wouldn’t be in an SEC filing, IMHO.