Replies to post #754067 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Does anyone know if FlaskWorks facility, here in the US, is actually doing any of the work required for acceptance on the EDEN unit, or are they limited to development of the EDEN, but all testing and acceptance actions on it only happening in Sawston.

I'm thinking that if the FDA is involved it would be desirable if at least some of the work is being done here in the US. If it's purely UK approval first, then everything occurring at Sawston may be the answer.

The last update from the NWBO was that they were working on design details. Once those complete they will/did order the units. Then the uints have to be manufactured and delivered.

NWBO let us know that, so they will disclose progress. They have not disclosed actually having the units in.

As far as the rest. The FDA has no reason to be involved regardless of where the work is. GMP is required if they want to use for the US. The much bigger comparability issue is moot as they need a BLA to compare against.

[starric]

I would assume they are doing something there. Agility Labs/ Triple Ring Technology offers has a decent umbrella covering different services including verification and validation.