Actually, that interpretation misreads both the structure of NWBO’s disclosures and the regulatory process itself.
Yes, Flaskworks is in the pre-approval submission phase, but that doesn’t mean it’s not integrated. From the Q1 2025 10-Q:
“We are also continuing integration of the Flaskworks EDEN system at our manufacturing site, and preparing for additional regulatory filings and inspections relating to this system.”
That’s not conceptual. It confirms Flaskworks is being implemented operationally and prepped for regulatory review.
The phrase “not yet included in existing filings” doesn’t mean excluded from the strategy. It means Flaskworks is being added through a structured pathway, likely via variation, which is routine. Especially now that SI 2025 No. 87 is in force in the UK, enabling modular GMP systems under a Control Site license.
This isn’t about whether Flaskworks is live at commercial scale today. It’s about whether the infrastructure, inspection trail, and filings show that it’s being positioned for regulatory deployment.
They do. And they’ve said so on the record.
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