NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

They are “preparing for additional regulatory filings and inspections relating to Flaskworks.”
This is critical language: Flaskworks is not yet included in existing regulatory filings. Regulatory approval processes for the system are pending, not underway or complete. Active integration work at Advent further confirms that the system is not production-ready or certified. No mention of regulatory submission or validation runs completed.

Flaskworks is in the pre-approval, data-generation phase not yet regulatory-approved nor fully integrated into NWBO’s official production strategy.