Replies to post #777498 on NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

Sure

yes sure sure, If you still think the MHRA will not approve DCVAXL after stating this today "A cancer patient could now have their immune cells collected, modified to fight their specific cancer, and returned within days rather than months," then its you who is living in a fantasy world. But please share the other personalized immune cancer treatment MAA application that the MHRA is referring to? Or do you think the MHRA is just saying that today and then turns around and declines the only immunotherapy application for kicks and fun, you know, British humor and all that?

You dont seriously believe that do you?

[Slave1]

Sure is...  Exactly right. That quote reflects the legal reality under SI 2025 No. 87, not a hypothetical.

Before SI 87, the MHRA’s Specials framework allowed one-off use of unlicensed medicines, but it wasn’t designed for personalized cell therapies like DCVax-L. It didn’t support decentralized production, kit-based combinations, or cross-border logistics.

Now it does.
SI 87 formally allows:

• Patient-specific ATMP kits (like DCVax-L + Hiltonol) to be manufactured and delivered without full MHRA approval, so long as each dose is labeled for a named patient.

• Modular manufacturing, closed-loop devices like Flaskworks can now be deployed across sites under a single Control Site license.

• Combination delivery, DCVax + Poly-ICLC, G100, or Decoy can be paired in real time without triggering new authorizations.

• Export and return, tumor tissue can be shipped to a licensed facility (like Sawston), and cryopreserved vaccine returned for injection.

• Named-patient labeling not a brand, just a person.

That’s what this system is built around.

So yes, the regulatory model no longer requires traditional approval for what DCVax is already doing under Specials.

This isn’t a workaround.It’s codified law.

And it’s already live.

Now ask yourself (God forbid), if you or your loved one had stage 4 metastatic carcinoma that was inoperable and 100% lethal, would you be willing to pay out of pocket?

got DCVax?