Replies to post #773196 on NorthWest Biotherapeutics Inc (NWBO)

[FeMike]

That’s certainly a fair and logical way to look at it.

Market thinks otherwise, but we’ll see.

[manibiotech]

Hi Dennisdave
So once comment period is over , how long will it MHRA to address the concerns raised - a month? , 2 months ? , more ?When they give response to current comments /concerns that were raised by June 30, will there be another comment period ?What  is the process and the timeline involved ?

[kfa670]

That's well put Dave

[Doc logic]

dennisdave,

Agreed! How often have we seen regulator guidance changing over the years during the rise of DCVax-L to accommodate new modicum’s of treatment response, adequate measures and an actual pathway to advance their cell therapy? FDA has changed guidance, MHRA has changed guidance and others have learned to bend as well. This is all part of what I have referred to for years as sod busting and during this time manufacturing has been being brought up to speed from a point where Linda was pleading for help in 2018 to where we are now without any help from big pharma along the way. They had their chance to see and properly value what others were seeing back in 2012. Only Mr. Neil Woodford saw and bought into the vision with conviction but then the hope we all had that answers could come sooner never showed up as hoped for in that hoped for time frame and he got anxious, maybe even nudged by others and he got caught with his hands in the cookie jar and put in time out, his shares sold and NWBO nearly forced into bankruptcy.
Now, all these years later would be the perfect time for those with vision and ability to understand Linda’s plan to follow her lead and support the next steps to moving DCVax into patient accessibility after at least one regulator got their act together to make a way for DCVax. With this, I do expect Linda to lay out the plan forward and a system of accountability once approval occurs.
The lack of NWBO’s accountability to shareholders has to date and of certain necessity, not been a high priority to remedy because of all the outside influences on share price and timing of advances apart from Linda’s own very deliberate nature that reduces the risk of fatal mistakes for DCVax advancement. Linda had to scramble for ways to maintain investor interest in spite of the great length of time everything would take. We all came to know this as dangling carrots. Once any approval occurs the carrot dangling won’t be acceptable any longer. At that point it’s time for a plan and support in place to make it happen ; ). Best wishes.

[Chiugray]

Dennisdave, Agree and well said. I am putting 1 +1 together.

1. MHRA Draft Guideline on the Use of External Control Arms (ECA) Based on Real-World Data (RWD)
Draft publication: May 20, 2025.
Consultation closes: June 30, 2025
Implication: By early July, MHRA has all feedback, and can theoretically implement the principals of the final guidance document
Key: Directly validates DCVax-L MAA’s use of ECA methodology

2. SI 2025 No 87: The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025
Date signed into UK Law: January 23, 2025.
Effective Date: July 23, 2025
Key: DCVax-L approval under this law, automatically includes the regulatory framework (the “blueprint”) and should expedite the approval and scaling of the automated Flaskworks Eden system for commercial use.

The convergence of these two events into July 2025 tells me that the UK government and MHRA are proactively shaping the regulatory environment to embrace and facilitate the approval of innovative, complex, and personalized medicines. I believe these laws had approving DCVax-L in mind when they were put together. As an investor this looks very positive, and the UK is being very supportive.

[exwannabe]

The guidance highlights situations where RCTs are unethical or unfeasible, such as:

There are over a dozen large randomized trials in GBM running as we speak.

Start with this 672 patient trial with a personalited DC vaccine.

Or of course Keynote D58., a 790 patient trial with TTF plus Keytruda that Merck is colloborating on.

Why is it others can run these trials and NWBO can't?