Replies to post #799288 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

You’re ignoring that this has been the long term plan all along, and you are lying that it can’t be done the way it was planned. Instead:

In pharmaceutical manufacturing, a company can initially gain approval based on a clinically-used process, then submit a Type II Variation (a major change) to switch to a more efficient, scaled-up process once it is ready and validated. This variation requires submission of new data to demonstrate that the product made by the new (Flaskworks/Grade C) process is equivalent in quality, safety, and efficacy to the product made by the clinical (Artisan/Grade B) process.

[beartrap12]

DennisDave, Management is talking to MHRA officials. You can't get any better info on how to handle this issue of manufacturing change than to talk to the regulator. If there's any question about Flaskworks replacing manual in six months (which there isn't, IMO) I'm sure NWBO would amend the MAA to please the regulators. It's kind of silly for you or others to argue this point.

[attilathehunt]

Yes tomato sauce...it's already canned!
Approval with B!!!!