Replies to post #493793 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Excellent, but why do you think Shashi Murthy exclaimed they still had a lot of work ahead of them to finish out the process (including validation) when he spoke at ASCO a month ago, and why would Marnix have spent so much time discussing the present manual system? Could it be that they are going to start commercially manual and upgrade to automate months down the road, or do you think Shashi Murthy, after seven years of developing this system, got the “lot of work” done to finish automation readiness and validation in the course of the last month? I know you are certain this is going to be a fully automated certification straight away after inspectors approve, but I’m sincerely wondering.

[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.

[eagle8]

Thank you for the clarification hyperopia.

GLTU