That’s one of the issues with not having entered into a partnership or some form of collaboration with a Big Pharma company. NWBO needs a larger player to carry their water with the FDA, and provide cover from other Big Pharma donors that exert influence.
Probably this is the reason why NWBO choose to have 4 SAP's, in 4 different countries. Just to de-risk and show the FDA there are other ways of getting DC-Vax to market.