Replies to post #772843 on NorthWest Biotherapeutics Inc (NWBO)

[FeMike]

Point of Care (POC) medicinal products: Medicines that, due to factors like very short shelf life or highly personalized nature, need to be manufactured at or very near the place where the patient receives care (e.g., in a hospital, community setting, or even at home).
* Modular Manufacture (MM) medicinal products: Medicines manufactured in self-contained modular units that can be deployed to different locations, allowing for flexibility and proximity to patients.

These don’t apply to DCVax at all.

It is not a POC medicinal product. It has to be manufactured at Sawston, in a clean room. Even with Flaskworks, it still requires a clean room, just not as stringent of one. It’s not POC at all.

What you are implying is that because of this, DCVax will be manufactured at hospitals. When approved, DCVax will be manufactured at Sawston and Sawston alone. Why do they need to wait for permission to manufacture at a hospital when it’s going to be manufactured in clean rooms at Sawston? This is just ignorant.

Stop.

[dennisdave]

So NWBO submitted a marketing authorization request for DCVax-L, relying on Flaskworks, without knowing (a) whether a law would be passed to allow Flaskworks, (b) whether Flaskworks would actually function as intended, and (c) whether Flaskworks would be approved within a reasonable timeline?

aha got it.