NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

For as late as an August approval, the only ray of sunshine that comes to mind is that by that time, the EDEN automatic manufacturing method would already have been validated....

NWBO stated in the 10K that it will be "several months" before they get the actual devices in so that they can validate them internally.

NWBO also said:

We completed the evaluation of three fundamentally different process approaches that the Flaskworks system could take, and chose the one that we believe will be optimal both operationally and to facilitate regulatory approval.

Different processes means once they vetted the device to go with they will need to run comparability trials to establish they produce the same DC-L. And those are clinical trials. Zero chance they would be ready to submit Flaskworks for use in commercial mfg of -L this year,

... and MAA submissions to other regulators would not be far off

Yet no word on that in the 10K. No word about an EU PIP. No word about a US based manufacturer.