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Slave1

07/19/25 2:21 PM

#776839 RE: barnstormer #776837

Totally fair to disagree. I would just add that while a press release might have been appreciated by investors, from a regulatory standpoint it is plausible NWBO had reasons to hold off.

Flaskworks may have been referenced in the original MAA, but prior to SI 2025 No. 87 the MHRA had no legal framework to approve it as a modular Control Site. That regulation was laid before Parliament on June 17 and does not come into force until July 23. Before that date, including Flaskworks would have required a Type II variation, a major change that involves comparability studies, validation, and potential inspection.

Waiting until SI 87 is live would allow NWBO and MHRA to finalize everything in manufacturing, labeling, and packaging under one legal framework without triggering post approval variation. It is not about concealing anything. It is about structuring the license cleanly and avoiding regulatory friction. Until we hear otherwise, that scenario fits the timeline.
Bullish
Bullish