NorthWest Biotherapeutics Inc (NWBO)

[kabunushi]

FWIW, a seeming important dimension of mfg planning and contracting: assuming that neither dcvax RA approval nor flaskworks are merely pipe dreams, then a speculative but very relevant issue is whether or not NWBO can get flaskworks up and running, fully tested, and vetted as a mfg vehicle for dcvaxl in time for the needed scaling up of mfg for making the vaccines after they receive full marketing approval, whenever that will be. There may be two key timing considerations in that they need to show they can produce in some quantity as an important element of their application to market dcvax (maybe too soon for flaskworks to officially be in play at all), and then the actual practical need to support the ramp-up of demand post-approval (maybe it's much more likely for flaskworks to be an important factor in NWBO contracts to have dcvaxl manufactured for ramping up into clinical use).

Assuming that flaskworks implementation and approval is reasonably close, meaning in X quarters and not in X years and as advertised it increases by an order of magnitude the quantity which can be shipped from a given size of cleanroom, then the contracts with 3rd party mfg firms at Sawston and at some 3rd party mfg in the US presumably would be under different terms than what can be done presently without flaskworks. In fact, the contract with CRL or other US maker would be very different because of the additional complication of licensing flaskworks to CRL.

I mean that it seems likely that we might see intersecting trajectories of RA application and the actual post-approval start of scaled-up mfg with the target for availability of flaskworks. At the least, that complicates the required mfg agreements unless flaskworks availability is not even in the unknown range of when the RA marketing approved commercial ramp-up will start. From the outside, we can only make very WAGs on the date for any marketing approval alone let alone how that timeline will intersect (or not) with the practical timeline for flaskworks to drastically change mfg throughput and per-dose cost of mfg. But I guess it is more likely than not that the timeline for flaskworks will be an important factor in those contracts, maybe right out of the starting gate.