NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

biosectinvestor, I completely disagree with your characterization of the difference between the manual vs automated culture process, but no point in getting into it.

I should probably clarify though, that I think Advent’s initial evaluation of the Flaskworks device prior to acquisition, was simply for internal validation, and the commercial prototype will go through the qualification process; DQ, IQ, OQ, and PQ, then comparability testing for the regulators. I agree that the FDA does not require human studies for comparability of the Flaskworks system itself, and that Advent may simply do the first minimal qualification of the system. I guess my point was that Flaskworks is only part of a much larger Comparability Protocol, which will take longer to accomplish, and require actual patients to confirm that Advent can achieve the higher commercial specifications and volumes, for the new manufacturing process using the multiple automated systems necessary for commercial production.