NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

exwannabe,

If optimization was occurring during the Phase 3 trial and this negated FDA approval and the Germans approved it for HE anyway because their optimization made it work even better, what kind of pressure do you think that would put on FDA? I am not saying this is the case but as far as I read equivalency, proof that a product is as good as or better than what was in the original treatment is all that matters. There may be some wiggle room too if cell selection within what is already being produced is all that is changed right? It's technically not a new product because it was already being produced. Best wishes.