Replies to post #796191 on NorthWest Biotherapeutics Inc (NWBO)

[jesster64]

"I thought since the MHRA released a paper, the last couple of days, saying they are rewriting the rulebook for rare and personalized therapies and that it will be issued in about a year...suggests to me, we have to wait.....I'm thinking, we didn't get approval the traditional path and the delay was/is due to this rewrite...so maybe we still a ways to go before we hear."I have to disagree here. "

I don't believe this is true. For GBM, I believe we will be approved soon, 20% possibility this week because of the CHM meeting. But it appears as though nothing has leaked. NWBO applied for approval the old fashioned way. They should get approved the same way. The rewriting the rulebook helps us with future submissions. JMO

[BlackMountain]

So you're effectively saying we should not expect approval within the next year? Jesus, I hope you're wrong.

[dennisdave]

I thought since the MHRA released a paper, the last couple of days, saying they are rewriting the rulebook for rare and personalized therapies and that it will be issued in about a year...suggests to me, we have to wait.....I'm thinking, we didn't get approval the traditional path and the delay was/is due to this rewrite...so maybe we still a ways to go before we hear.

Hope I'm wrong...Which I have been the last 24 months!

I get why you’re thinking that, but the MHRA paper does not mean they have to wait for the new framework before approving DCVax-L.
1. The paper is forward-looking policy, not a pause button.
It says the MHRA is designing a future framework for rare/personalized therapies, with consultation and publication in 2026. It does not say that current applications are on hold until then, nor that approvals will wait for the full framework.

2. DCVax-L is being reviewed under the existing ATMP regulations which already allow approval.
This pathway already exists and has been used for CAR-T therapies, gene therapies, autologous cell therapies, etc. DCVax fits into that system today.

3. The new paper is essentially MHRA saying publicly: “We need a better, scalable model for these kinds of therapies with faster approval.”
That aligns with DCVax in a broader sense, but it does not mean DCVax must wait for new rules while being under review of the present ATMP regulation. If anything it would have been great if this framework had existed 2 years ago then we would have already been approved.

4. If anything, the fact that DCVax-L is deep in review before the framework exists makes it more likely they could become one of the first live examples the MHRA uses. They can approve under current rules, then adapt DCVax-L into the new framework through post-approval variations if necessary.

5 I’m still holding on to the “couple of months” timeline Ashkan hinted at back in mid/late September.

[Red_Right_Hand]

The framework/guidebook discussed in that paper may not be finalized for about a year, but the principles upon which that framework is being built exist today.

[Gus1212]

I think that I am going to Puke!

Maybe Twice tonight

Who is going to Puke with me!