I agree this is probably the strongest argument NWBO has, and you explain it well. From a risk-management standpoint, it is reasonable to maintain artisan as the intended route until another method is formally approved, especially given the genuine uncertainties around construction, long-lead materials, and certification timelines.
That said, this is also why I’ve said earlier that the recent PR was poorly worded and that the company would have been better off keeping quiet about Flaskworks at this stage. The moment you publicly describe a future manufacturing route in concrete terms, you risk blurring the line between contingency planning and declared commercial intent. What complicates things further is that NWBO has now articulated a fairly specific timeline for Flaskworks. Once you do that, the argument that everything is open-ended uncertainty becomes weaker. If delays occur, that in itself is not an issue for the MHRA — regulators are used to timelines slipping. The issue is not delay, but how intent is framed at the time of MA.
So I don’t disagree that NWBO can credibly argue “artisan is the intended route for now.” I just think that by speaking too openly about Flaskworks and by attaching timelines to it, they have made that argument less clean than it needed to be.
Still, it’s a nuanced point, and reasonable people can land on different conclusions here.
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