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dennisdave

11/20/25 1:35 PM

#798780 RE: exwannabe #798777

first of all you make a lame argument. What if you dont have a girl or boy friend by the end of the day will you then stay single the rest of your life, ex?

But Ok You haven't paid attention to what I said.

You can’t validate Flaskworks/Eden before the units are physically delivered, installed, calibrated, assigned to a licensed cleanroom, released by QA, and integrated into the site’s EM/QC/SOP systems. That only became possible very recently. The 10-Q states the Flaskworks/Eden units were only recently delivered
NWBO literally disclosed that they sourced two major pieces of C-Lab equipment they avoided 10–12 month procurement delays; these were just acquired
You cannot run IQ/OQ/PQ before the hardware physically arrives. Delivery = the earliest possible starting point.

Adding automated CMC to an ATMP review always adds time. Look at Novartis CAR-T, Kite, BMS Breyanzi, Orchard, Bluebird — every one of them needed 6–12 extra months once manufacturing automation was integrated. It’s normal biology and normal regulation, not “slow play.” But you are saying these big players slow-played it as well? Ok.

So if NWBO hasn’t started certain Eden testing yet, that’s not a delay it’s simply the required sequence. Validation=> engineering runs=> comparability=> submission => MHRA review. That’s how it works for every ATMP.

This pushes approval toward mid-2026. Not bearish, just industry reality.