NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

I agree that it was probably viewed as necessary to commercialize in the way that LP wants to commercialize it and that the application appears to me to be for an automated system, and that they needed to upgrade the Flaskworks system from a clinical system to something appropriate for commercial manufacturing. I do think they could have proceeded with approval as they had it, and that the company determined that that was suboptimal, for a variety of reasons. While it is a lot of work to do what they have done and now to also go through the approval process, to do it post approval, when they have already scaled to do it manually, would be unnecessarily costly. And you’d need a lot of employees to train that then you would no longer need.

That would be very expensive and wasteful.

So they have reasonably gone forward in the manner that they have gone forward. There was no regulatory requirement that it be automated and in fact Car-T therapies are the poster child for the manual method.