Replies to post #777504 on NorthWest Biotherapeutics Inc (NWBO)

[FeMike]

Regardless, I will put you in the camp that agrees MHRA approval is not needed for -L.

The pumpers have gone even further off the deep end than I thought with this.

They have flown straight past my target of "this means DCVax approval today" and have crash landed somewhere over the rainbow in "DCVax doesn't even need MHRA approval"-land.

I mean, talk about a 180, jumping the shark, whatever you want to call it. The pumpers are literally out here saying DCVax doesn't need to get approved by the MHRA.

[dennisdave]

That interpretation doesn’t hold up when you read the actual text of the MHRA announcement. Yes, CAR-T therapy is mentioned as one example, but the regulatory framework explicitly applies to a broad range of innovative products, including cell therapies, gene therapies, tissue-engineered products, and more. DCVax-L falls squarely within the “cell therapy” category, as it involves autologous dendritic cells modified to target each patient’s tumor.
Besides, CAR-T therapies have been around in the U.S. since August 2017, and in the UK beginning January 2019, so bit strange to come up with legislation for that treatment now 7 years later isn't it?
Also, the current CAR-T process has always depended on centralized, highly specialized production. This new law enables decentralized, small-batch, bedside manufacturing, something CAR-T doesn't do or is planning todo. DCVAX is.


The language in the article is telling: “A cancer patient could now have their immune cells collected, modified to fight their specific cancer, and returned within days rather than months.” That describes DCVax-L’s mechanism of action almost verbatim. It’s not limited to CAR-T. In fact, DCVax-L may be even more compatible with this new framework than CAR-T therapies:
It’s non-genetically engineered, which reduces complexity.
It’s being adapted for closed-system, point-of-care manufacturing with Flaskworks.
It targets solid tumors, where CAR-T has failed to deliver.

The new law SI 2025 No. 87 allows decentralized, modular manufacture for personalized treatments and sets the regulatory groundwork for therapies like DCVax-L to be made near the patient. That’s the entire point. So no, the MHRA isn’t just talking about CAR-T. This is clearly about enabling a whole class of next-gen personalized cell therapies, and DCVax-L fits the bill.

So now what?

now you open your broker's account and buy the number of NWBO shares back you are short to not be completly financially destroyed after the inevitable MHRA approval for DCVAXL is announced. Your welcome.