Replies to post #826109 on NorthWest Biotherapeutics Inc (NWBO)

[KRISGO]

I don’t think any of these will impact the share price other than MHRA approval, IMO. Hopefully, I’m wrong.
Sorry, this long wait has been really frustrating.

[Investor082]

You forgot the real catalyst that you were pumping non-stop last year:

10.5 year survival data in May 2026, resulting in NICE evidence submission? LOL! ;)

[meirluc]

With regard to approval time or anything else, I take an AI opinion with a few salt grains but those opinions are probably as good as ours (shareholders) so here is one of those opinions with an emphasis on July.


In light of the fact that you recently assessed that MHRA's approval of NWBO's MAA will occur sometimes between July and October 2026, what in your opinion as to the most likely month of this approval

"The most most likely month for the MHRA's approval of Northwest Biotherapeutics' (NWBO) MAA is July 2026.
Rationale for a July 2026 Approval
Manufacturing Readiness Alignment: NWBO targeted Q2 2026 for fully establishing manufacturing in its expanded, upgraded Grade C suites at the Sawston facility. Because the MHRA assesses and approves the physical production infrastructure in tandem with the biologic itself, a decision cannot legally or practically precede final facility validation. A July announcement perfectly succeeds this Q2 operational integration.
Resolution of the Regulatory Overhaul: The application has faced a prolonged timeline due to new UK frameworks, specifically the Medicines for Human Use (Clinical Trials). Regulations that took full effect on April 28, 2026. With the formal implementation of these decentralized manufacturing and data-transparency protocols now complete, July provides the necessary buffer for the MHRA to issue a "future-proofed" authorization under the finalized rules.
Extended Review Precedents: Biologics that cross the two-year review threshold typically conclude immediately after final technical clock-stops—such as label negotiations or localized site inspections—are resolved. Given that the independent Commission on Human Medicines (CHM) advanced its side of the process, the early side of the window (July) is heavily favored over further stagnation into the autumn.
·Probability Across the July–October Window
Anticipated Month Probability Primary Driver
July 2026 High (approx. 55%) Immediate post-validation of Q2 Sawston infrastructure and April 2026 legal framework adjustments.
August 2026 Moderate (approx. 25%) Standard administrative turnaround if final labeling text extensions spill past mid-summer.
September / October 2026 Low (aprox. 20%) "