Replies to post #814305 on NorthWest Biotherapeutics Inc (NWBO)

[manibiotech]

I had said even 2-3 years ago that they bit more than they could chew in my opinion . They should have partnered with or hired folks with experience in this domain and track record of getting through regulatory frameworks and approvals . 

[sukus]

AI might be able to help why the waiting is still going on. I learned from AI that UK revamped a lot of regulations. UK transformed themselves so much. But in order to do that they spent 2024 and 2025 doing the preparation works. A lot of works indeed. For those who waited patiently such as NWBO I was told by AI ended up in a better shape. Many of those new regulations just introduced in January. Some which are really good one introduced in July 2025, the SI 87. I have asked AI Gemini to analyze those new regulations, I am amazed by the answer. This is what it said. If NWBO was approved in 2024, it would be a mess. Because the regulations were not designed for personalized cell therapy. If NWBO get approval in 2026, NWBO is in much better positions. AI Gemini stressed that the castle has been built, the cell therapy innovations are invited inside. Yes it is frustrating to wait. But if we know why the delay  from AI that has no emotion but can see clearly the structural changes going on, we may feel a lot better. I tap those AI more and more to find out more. 

[flipper44]

If they are in the alignment pathway (a different portal), which we must assume since they have literally otherwise ghosted NICE for nine/ten months, (Katy from nice said on January 5, 2026 no response from company since April 2025) then NWBO/mhra/nice are simply timing mutual announcement for sometime AFTER March 31, because April 1st is when the new reimbursement levels take effect. NICE effectively misled me, imo, by intentionally getting ghosted by NWBO, imo.

If a company were actually ghosting NICE for 10 months during an active MAA process, NICE would have formally suspended (aka: see Vorasidenib) or terminated the appraisal (ID836) to save resources, imo, unless it was simply in a different system/portal that NICE pretends to ignore, where all three parties (nice, MHRA and NWBO consultants) are communicating all the time.

The last update on this subject from the company was received by colleagues in April 2025. Colleagues in our medicines evaluation team last emailed the company in mid-December 2025 asking for a further update. They have not yet received a response but if no reply is received they will contact the company again in February 2026, in line with NICE’s usual processes for this situation.

NICE, January 5, 2026

Here was my December 5 question.

Could you please tell me the date and time the company responded to you in order for you to send the email below “still fully occupied and engaged”. I assume the company responded to you sometime between December 3 and December 5, but sometimes NICE simply responds by looking at older responses and making certain nothing has changed in the filings. Either way, it’s important to me.