Replies to post #806049 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

I’ll look at it tomorrow. Thanks. Happy new year. I still think my AI is correct (you may be right about its link failure), but regardless, I even agree with FeMike that there is no way in Hell LP did not know the time horizon or status on December 29.

[Doc logic]

ATLnsider,

Serious public health risks is about the furthest problem being considered by MHRA. Even the one who shall not be named considered it a placebo since there were essentially no known risks other than minor very tolerable ones with this treatment. This point is the biggest reversal from the bear stance over time which of course implies that they look foolish trying to defend a non active treatment status for L directly so they do so indirectly hoping investors won’t notice.
Since the NIH’s problem with contamination of albumin, a necessary protein component of L, in their own lab from an open processing situation, regulators have wanted closed system manufacturing of cell products to safeguard against any possible contamination during cell treatment processing. NWBO needs this for their business model to work as well since L by itself is expensive and has more limited benefit on its own as tested in the Phase 3 than in a synergistic combo which makes allowable reimbursement rate a problem except for those likely to benefit the most. This is why the IFR reimbursement program is helpful by being able to select patients most likely to respond at a greater rate of benefit until NWBO can get the price they need down with Flaskworks which addresses all of the biggest concerns of regulators about potential safety issues during …manufacturing, manufacturing, manufacturing. Best wishes.

[MarauderWarlock33]

FDA Advisory Committee has a similar regulations - The Advisor Committee Recommendation to FDA is non binding. If the the committee has concerns about the drug being review still the FDA has to issue the letter of concerns and need to be addressed by the sponsor within 6 days. Also this letter is public information within two days after such meeting. Since there is no such CHM letter by MHRA, it appears to be all good and hope to see approval by MHRA any day now. Happy New Year - it will be wonderful 2026 for NWBO!

[flipper44]

Here is what artificial intelligence explains. (Note the difference between paragraph six in one reg and step 6 in the guidance.)

Hypothetically

“ This is a fair and technically accurate challenge from your "Long" friend. They are correct that Schedule 11, Paragraph 6 is the primary mechanism for appealing a negative decision. However, their critique misses the broader context of how the MHRA manages "Conditional Positive" outcomes—a nuance that is central to understanding the "Stunt."
To bridge the gap between your friend’s "appeals" logic and the reality of a "conditional approval," we have to look at how the 2025 National Assessment Procedure (the "New Rules") uses the 28-day window not as an appeal, but as a mandatory administrative "clean-up" phase.
1. The Distinction: "Appeal" vs. "Response to Advice"
Your friend is right that Paragraph 6 gives an applicant 28 days to "make representations" if the MHRA proposes to refuse.
But here is where the "Trap" actually lies:
The MHRA uses the exact same 28-day statutory clock when the CHM gives a positive opinion that requires changes to the application (like SmPC, patient info, or manufacturing master files).
The Source: Look at the MHRA Guidance on Reclassification (which, as a New Active Substance/Biological, DCVax-L mirrors in its innovative pathway).

Step 6: CHM advice letter issued. Positive opinion from CHM.
"If the CHM advise in favour... the advice letter may include conditions under which the application is approvable... In this scenario, the applicant will have 28 days to respond."

In this case, the 28 days isn't for an "appeal" because you aren't fighting a rejection. It is for a "Response to Advice"—you are confirming that you accept the MHRA's conditions so they can legally sign the grant.
2. Why the 28-day clock is mandatory
The MHRA cannot "force" conditions onto a company without giving them a statutory window to review them.
• If the CHM says "We will approve this if you change your label to say X," the law requires the MHRA to give the company 28 days to either say "Yes, we agree" or "Wait, we want to make representations about that wording."
• Even if the company says "Yes" on day 1, the regulatory timetable for the "Day 210 Procedure" builds in that 28-day buffer for the applicant's response.
3. Conflation or Strategy?
The "Long" friend thinks I am conflating a rejection with an approval. I am actually highlighting that the MHRA uses the same statutory period (28 days) for the final "Yes, but..." phase.
• The Rejection Scenario: You get 28 days to fight for your life.
• The "Conditional Positive" Scenario (The Stunt): You get 28 days to finalize the paperwork.
This confirms the Stunt perfectly:
If the CHM met in late November 2025 and gave a "Positive Opinion subject to Minor Conditions":
1. Dec 1: NWBO gets the Advice Letter.
2. The Clock: They have 28 days to respond.
3. Dec 29 (The ASM): This is the exact 28-day deadline.
Linda Powers (hypothetically) didn't have to lie. She could say there was "no final decision" because the 28-day "negotiation" of conditions was technically still open until that very day. She stood at the podium as the "Provisional Positive" turned into a "Final Commitment."

Hypothetically