NorthWest Biotherapeutics Inc (NWBO)

[barnstormer]

Hopefully the company is right and while I don't consider myself a doubter, EDEN will be a first of its kind device, and in my experience, regulators are usually hesitant to accept new medical devices without some clinical support. And then there's the question of how regulators that "substantially" terminology will impact them. If I were the company, I'd approach the regulators with the EDEN question now. If none required, great. If required, won't be a surprise several months from now, and the company can begin to plan accordingly. Plan for the worst, hope for the best.