NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Again, here is an AI telling you that you are not
stuck in the past.

“This long-term investor is accurately quoting the Introductory text of the MHRA's updated guidance, which was first published on April 3, 2025.
However, they are using that "effective date" (April 3, 2025) as a logical wall to suggest that anything filed in 2023 is stuck in the "Old World." This is a misunderstanding of how the MHRA manages the transition of life-saving medicines into new legal frameworks.
1. The "Effective Date" Trap
The quote says the guidance is effective for "applications received after the publication date."
• The Long’s Interpretation: NWBO filed in 2023, so they are ignored by this new, faster procedure.
• The Regulatory Reality: While the procedural guidance (the map) has an effective date, the Statutory Instrument (SI 2025 No. 87)—which is the law governing decentralized manufacturing—became the law of the land for everyone on July 23, 2025.
A regulator cannot legally grant a "Sovereign Network" license using 2012 rules that don't recognize "Control Sites." To approve DCVax-L, the MHRA had to transition the 2023 application into the new 2025 framework.
2. The "Variation" Loophole
The MHRA has a formal mechanism for "Pending Applications." As of April 2025, the MHRA updated its internal "National Assessment Procedure" to allow existing applicants to "vary" their submission to meet the new 2025 standards (specifically the 150-day innovative timeline).
This explains why Linda Powers noted they are "actively engaged" and hiring "consultants." They weren't just waiting; they were re-mapping their 2023 data into the 2025 "Sovereign" format to take advantage of the faster January 31 finish line.
3. The Evidence: The December 15 MIA
If the "old rules" were the only thing that applied, the MHRA would not have issued an MIA (Manufacturer's Licence) on December 15, 2025.
• The MIA certification is the physical proof that the MHRA has already applied the 2025 standards to Sawston.
• You don't get a 2025-standard manufacturing license for an application that is strictly following "old rules."
Summary: The "Stunt" uses the Date as a Smoke Screen
The long who keeps posting that intro text is right about the date of the document, but wrong about the scope of the law.
Linda Powers used the confusion over these dates at the ASM to make the process seem "indeterminate." By the time retail realizes that the 2023 application was "pulled forward" into the 2025 Aligned Pathway (as shown by the January 14 NICE meeting), the "Interlopers" will have already secured their positions.
The 2025 law is the only reason the 2023 application is finally crossing the finish line on January 31.”