Replies to post #827994 on NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

I don't believe it's true that a definitive statement from the regulators that's not official approval is a material event. If NWBO is involved in developing the label, they most certainly know they have approval the only question is for precisely what? Companies don't reveal that they're working on the label, or anything else they're told by the regulators, they wait until they're notified officially that they have an approval.

It was theorized by some that they were working on the label some time ago, no one outside the company and regulators know for sure. I think it's very clear that LP intends to say nothing until she can say what the official decision of the regulators is. It doesn't mean she can't announce other things, but not what is happening with the UK regulators.

Gary

[GoodGuyBill]

Brazen, generally speaking, your interpretation leaves a major gap: If these actions don’t reflect near-term approval or direct late-stage MHRA alignment, then what is the rational basis for a cash-scraped company to execute the most complex and expensive commercial-readiness program in its history right now?

Also, let me respond directly to your points:

1. “These steps could reflect unresolved CMC issues.”
Those actions can be consistent with unresolved CMC issues for a well-capitalized Big Pharma, but not for a small, cash-scraped, no-revenue biotech. A BP can run parallel commercial readiness and CMC remediation for years. NWBO cannot.

For a company with NWBO’s balance sheet, U.S. tech transfer, SOP overhauls, validation campaigns, Sawston expansion, leukapheresis buildout, and Flaskworks integration are not “routine maintenance.” They are high-commitment, irreversible, multi-year expenditures that only make sense when the regulatory timing is aligned.

2. “A cash-constrained company can still spend if the alternative is worse.”

I would generally agree with you if we were discussing a well-capitalized company. Of course a cash-constrained company can still make expensive moves. But a no-revenue microcap cannot take on multi-year, irreversible commitments without late-stage regulatory alignment — the financial risk is too high.

Your logic applies to Pfizer. It does not apply to NWBO.

3. “Intent is not approval.”

True — but that’s not the question.
The question is: Is it plausible that NWBO has no signal at all from MHRA after 2.5+ years of review?

If NWBO truly had no insight into the review, then what is the basis for commercial intent at this scale, given their financial position? A microcap does not build a leukapheresis center and expand manufacturing “blind.”

4. “If the feedback were strong enough to justify spending, it would be material.”

You’re assuming “regulatory feedback strong enough to justify commercial readiness” must also be “material enough to disclose,” but that’s not how regulators communicate. Late-stage MHRA feedback typically takes the form of commercial-readiness expectations — capacity, validation, comparability, and patient-handling requirements.

These are directional, not determinative. They guide internal planning but do not guarantee approval or meet the threshold of materiality. So yes, a rational management team can act on non-material late-stage signals without claiming “approval is close.”

5. “Routine RFIs and CMC questions can explain the preparation.”

Routine regulatory feedback can explain some preparation, but it cannot explain the scale, cost, and timing of NWBO’s actions. RFIs and CMC questions don’t require U.S. tech transfer, leukapheresis construction, or multi-year validation campaigns — those are commercial-readiness moves, not routine remediation.

More importantly, routine feedback happens early, not 18–24 months into the review with construction completing this summer. The timing shows MHRA has already shifted into late-stage commercial-readiness expectations, not basic deficiency cleanup.

Of course, neither of us has a monopoly on the facts regarding approval. We will see soon enough. Cheers and GLTY.