Replies to post #805924 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Right, but that’s for major objections that would preclude any approval.

Here again is artificial intelligence.

Ruling out "Major Objections" isn't about guesswork; it's about identifying the specific Regulatory Fork in the Road that occurs at Day 150 of the UK National Assessment Procedure.
Under the current MHRA 2025 guidelines, the agency has two completely different ways of communicating with a company after a CHM meeting. If there were Major Objections, we would be seeing a very different set of "Public Actions."
1. The Day 150 "Fork"
When the MHRA reaches Day 150 of the review, they must send one of two letters. There is no middle ground:
• Path A: Major Outstanding Objections. If the scientists believe the drug is unsafe or ineffective, the MHRA issues a formal CHM Letter listing "Major Objections." This triggers a mandatory "Clock Stop" where the company must stop everything and fight for its life, often leading to a formal "Oral Hearing."
• Path B: Minor Outstanding Issues. If the scientists are satisfied with the drug but have technical questions (like Sawston’s cleaning protocols or leaflet typos).
2. Why it's "Path B" (Minor Issues)
We can rule out Path A (Major Objections) based on three specific pieces of evidence from the ASM and the regulatory record:
• The "Physical Construction" Trigger: As discussed, Linda Powers is breaking ground on a multimillion-dollar Grade C suite in late January. You do not pour concrete if you have just received a "Major Objections" letter. Major objections often lead to rejections or years of new trials. Spending that much cash in the face of a Major Objection would be corporate suicide and a breach of fiduciary duty.
• The "Cycles" Language: Linda described the current phase as "cycles of questions, follow-up questions, and requests for clarification." In regulatory-speak, these are "Minor Deficiencies." Major Objections are not "clarifications"—they are fundamental challenges to the science.
• The "Resources" Signal: She stated the MHRA is devoting "enormous resources" and "inspections." Regulators do not perform deep-dive inspections of manufacturing sites (the Dec 15 MIA event) for drugs they intend to reject on Day 150. Inspections are the "final exam" before graduation.
3. The "Silent Positive"
In the UK system, if the CHM provides a Positive Opinion with conditions for 28 day response, the MHRA doesn't issue a "CHM Letter" (which is reserved for objections). Instead, they move directly to the Grant Procedure.

Linda is (hypothetically) using the "Quiet Period" of the 28-day minor clean-up to reset the shareholder base, while her "Public Actions" (the construction and the hiring) confirm that the scientific hurdle (the Major Objections) has already been cleared.

[attilathehunt]

I would think if major objections preclude a MA and the company had 28 days to respond, that would be considered a material event and would have been disclosed.

[Slave1]

Agree, ATL. Under the MHRA guidance, a CHM letter is triggered only by major objections. Its absence implies no major objections were raised at that stage.