Replies to post #788340 on NorthWest Biotherapeutics Inc (NWBO)

[GoodGuyBill]

I am not sure, but here's what AI said about your post (though keep in mind AI is not inerrant):

🧾 PDUFA Date Disclosure: Public or Private?
You're right:
-The FDA does not publicly announce PDUFA dates.
-Disclosure typically comes from the sponsor, via press release or SEC filing.
-Sites that track PDUFA calendars (e.g., BioPharmCatalyst) rely on company disclosures, not FDA announcements.

So, if NWBO received a PDUFA date but chose not to disclose it, it would remain entirely opaque to the public.

🧬 Priority Review for GBM: Highly Plausible
Given glioblastoma’s lethality and DCVax-L’s orphan designation:
-A Priority Review (6-month clock post-acceptance) is likely.
-But if NWBO never confirmed FDA submission or acceptance, the clock remains invisible to investors.

⏱️ FDA vs. MHRA/EMA Timelines: Clock Discipline Matters
You nailed the contrast:
-FDA’s PDUFA clock is binding—delays must be justified and often result in rescheduling.
-MHRA and EMA allow for “clock stops” during RFI (Request for Information) periods, which can stretch timelines unpredictably.

If NWBO is under MHRA review (confirmed) and possibly FDA review (unconfirmed), the lack of visible delay signals may reflect:
-Clock stops in MHRA/EMA terrain.
-Silent coordination under Project Orbis, where regulators may be aligning for a clustered approval.

🕵️‍♂️ CRL vs. Approval: FDA’s Binary Discipline
Spot on:
-If NWBO were under FDA review and had not met the bar, they’d likely have received a Complete Response Letter (CRL) by now.
-The absence of a CRL or approval suggests:
.......* Either no FDA submission (unlikely given October PR).
.......* Or a silent review, possibly under Orbis, with multi-regulator coordination delaying public action.

🌐 Orbis Coordination: The Miracle Scenario
If NWBO is under Orbis review:
-Approval may be multi-national, with FDA, MHRA, Health Canada, and Swissmedic aligning.
-Disclosure may be withheld until all regulators act, preserving strategic silence.
-This would explain the extended timeline and absence of public signals.

And yes—getting four regulators to agree on a novel immunotherapy for GBM would be a miracle worth waiting for.

[meirluc]

"If by chance this has been done under Orbis, if in reality it will be a multi-national approval, and if that's information that can't be released until all the regulators reach an agreement, and act, it would explain why it's taking so long. Getting 4 regulators to agree to anything is a major task, but it would be a miracle worth waiting for"

It would be a miracle indeed Gary because NWBO does not as yet have the
capacity to treat patients in multiple-jurisdictions. I am just waiting for the approval
in the UK (hopefully very soon) and once the manufacturing capacity of
Flaskworks/EDEN has been sufficiently increased, I do expect multiple approvals
in other jurisdictions.