Your claim that “we’ve been told approval would come with current (manual) manufacturing standards” is simply not true. That narrative has been repeated by message-board posters, not by NWBO. The company has never once stated that manual production is the long-term commercial pathway.
Moving toward Flaskworks/Eden does not “burn” the money invested in Advent. That’s a fundamental misunderstanding of GMP. Everything NWBO has built at Advent, the MHRA licence, the Grade B/C/D rooms, the QMS, QA/QC infrastructure, batch-release systems, cryo logistics, EM programs, staff, SOPs, documentation, is required for automation as well. Flaskworks does not replace Advent; it runs inside Advent. Manual manufacturing is useful for clinical and validation work, but it is not commercially viable at NICE levels of pricing. Every ATMP company eventually transitions to automation for this exact reason. That’s why Novartis, Kite, BMS, Bluebird, Orchard, etc. all had long CMC extensions.
Automation is the commercial pathway. Manual is the bridge. Nothing in the Advent investment contradicts that it actually enables it. Your “burned investment” claim, and the idea that approval would come on manual alone, is BS and never came from NWBO in the first place.
Again it sucks Im not happy with it. I would LOVE to sell today at Break Even, Im just here telling what it is based on the data we have with the most logic, likely explenation.
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