Gary, I think the way you’ve laid this out makes a lot of sense, especially the idea that the FDA may have encouraged a UK led submission to quietly anchor Orbis participation across aligned countries like Canada and Australia. With the Phase 3 protocol already harmonized across those regions, filing in the UK first could absolutely serve as a regulatory foundation without triggering early disclosure. Your read on that is well grounded.
That said, I also see where Doc Logic is coming from. Under current U.S. law, a Biologics License Application is still technically required for commercial approval in the U.S., even if a therapy is approved elsewhere. That’s a structural fact. But something important changed recently that may reconcile both views. In June, the FDA launched the Commissioner’s National Priority Voucher pilot program, which is specifically designed for therapies addressing serious diseases, unmet need, or national interest.
This new program allows companies like NWBO to compress FDA review from the typical 10 to 12 months down to just 1 to 2 months. Even more relevant here, it allows sponsors to submit existing clinical trial data, including what was reviewed by the MHRA, and only requires submission of CMC and draft labeling 60 days before the final application. So yes, a BLA would still technically exist, but the process around it is now completely reshaped. What you described conceptually is now structurally real under CNPV.
So it’s entirely possible the FDA supported a UK first filing with the intent to pull that dossier into a U.S. submission under this new model. That would explain why no formal BLA has been filed yet and why the company has remained quiet about timing. The regulatory framework to support that strategy didn’t exist until June.
In short, the legal form of a BLA remains, but the surrounding process has evolved. Under the CNPV program, NWBO could receive FDA review in as little as one month using data already generated. It is not a departure from U.S. law, but rather a reflection of how the system is adapting to biologics like DCVax L that do not fit the old mold.
You’ve been ahead of this in more ways than one, and I think this may be the regulatory bridge between what you’ve sensed and what Doc has clarified. Appreciate how much thought and consistency you continue to bring to this conversation.
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