Replies to post #373453 on NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

foxhound02,

Thanks for the input. I was under the impression that manufacturing in European approvals had to be in place before Marketing Authorisation would be granted and that both Sawston and Charles Rivers Labs might be called on for that. Best wishes.

[longfellow95]

The BLA has to include all of the CMC Process Validation data.
If they want to use Flaskworks from the get-go, straight after approval, then all the Flaskworks process validation data has to be in the BLA. And that means doing all your comparability studies, before you submit the BLA.

If you've got an hour or more to spare, then this FDA video outlines expectations / requirements.

Or this timepoint:-

I expect UK and European requirements are broadly similar.
I'm assuming this is what is currently engaging most of their time and energy. It all has to be done before regulatory submission, if they mean to start their commercial manufacture in the way that they intend to carry it on. Otherwise you have to do a post-approval supplementary submission and then wait for that to be approved.
And getting on with all this, is more important than rushing out a topline announcement that is likely to come across as somewhat ambiguous and confusing to the average reader.