NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

I would suspect that 3 years ago they believed that they would have the EDEN approval some time ago.  In part they probably caused the delay by continuing to improve the EDEN.
I can't say if the EDEN as it existed year ago could have been approved, but it appears to be a much improved unit today, but also more expensive to produce. 
From the excellent report done on it, the problems found in similar units have been resolved in the EDEN.  It's very possible that once enough EDEN'S can be made to meet demand for DCVax-L, FlaskWorks may build similar units for others making it a major profit center by itself. 
Gary