NorthWest Biotherapeutics Inc (NWBO)

[Maverick0408]

I am 100% certain the application is not waiting for Flaskworks device. And none of the regulatory agencies require automated or semi automated manufacturing for approvals.

Having said that, I don’t believe they will need to run a new trial with Flaskworks to get the device approved. The Flaskworks device will just need to meet certain standards and produce some test results demonstrating they meet these standards (not that they may apply in this case but as an example - biocompatibility, disinfection/sterilization, etc). They will need to create additional SOPs around these processes and so on. Then they go through a similar audit process (by the regulatory body) like the MIA. My experience over the years has been in the Class II and III medical devices, so I am not quite sure what standards apply in such cases, but you get the idea….

The regulatory agencies are fairly accommodating in terms of volume ramp up, particularly for such novel treatments. They are there to bring safe and efficacious treatments to the patients as quickly as possible and not create additional roadblocks. They care about the quality and compliance of the manufacturing facility rather than the volume!