Gnawkz, In addition to the items Long listed, I would also add NWBO likely has to reserve and pay for facilities, staff, supplies, and equipment with Fraunhofer for estimated peak capacity +20%, maybe over 1 year commitments even though in month 1 actual volumes would be very low. This is the ramping up inefficiency, dealing with fixed overhead and inaccurate forecasting.
I also think Fraunhofer is a research institute which might be efficient at low-volume but not efficient at high volume production, ie all clean rooms are small catering to multiple clients that need only clinical trial quantity volumes. So acquiring more Fraunhofer capacity for DCVAX might have a premium associated with it. This is a guess, but I do know that the first 1-2 years are always more costly, different reasons for different companies but always see that. Additionally when DCVAX-L gets formally approved (pass Phase 3, full marketing) and the UK manufacturing facility is operating, there should be price competition between Fraunhofer and Cognate then, with resulting cost reductions.