NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Is it possible the ball is in NWBO's court. What if the regulators told NWBO that they're ready to issue a tumor agnostic label, but NWBO must show them a production facility ready to meet initial demands. Remember, when they agreed to accept the 20 tiny cleanrooms it was for GBM alone, tumor agnostic would require far greater capabilities.

I'm not saying this is the case, but if it were at least one of the larger cleanrooms at Sawston would need to be completed, the EDEN approved, and sufficient EDEN units installed at Sawston to undergo an inspection. In that few inspections require no corrections and reinspection's, that too could stand in the way of an approval.

This is purely speculation on my part, but I believe if tumor agnostic were in play, the EDEN approval would be mandatory to it happening.

Gary