NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

Hi Hyperopia, I was simply offering a slightly broader perspective. I don’t see the other company as offering an alternative to Flaskworks.

I don’t think other suppliers are building versions of Flaskworks at all but the software and all of the other equipment that helps manage the process of a factory that processes dendritic cells for medical product/vaccine.

All of the other needs you mentioned I expect can be purchased and repurposed as necessary. Most industrial processes have additional tools that can be acquired and purposed as necessary.

As for the comparability, I do not expect that human testing will be be necessary at this stage. I agree consistency will be preferred but consistency compared to the existing process should be straightforward and remember, this (Flaskworks) was already a commercial product, not just a classroom experiment, when NWBO bought it.

They are also initially doing a discretely smallish iteration, not a complete factory, but a small installation of Flaskworks. I expect the validation will be of a process at this stage that is more like phase 1 of their “factory” and later it will be more evolved to be more efficient, but at this stage it will be more along the lines of an already validated installation of Flaskworks that they would have previously sold to any company or lab, with a plan for expansion as they iterate it now with each additional installation to modularly expand production. I think that would be the easiest way to get started.

But the comparability studies I expect will not be perhaps as extensive as might be assumed. The FDA rules attempt to expedite this part of the process, so I think they will be in good shape to get this done asap. No idea when that will be, but perhaps faster than some presume, IMHO.