NorthWest Biotherapeutics Inc (NWBO)

[marzan]

yea, please go thru those comments one at a time if you have time, I skimmed thru them fast to catch any negative comments, but I didn't find many. But I found most of the comments were supportive of the guidance. I am 100% sure Duffy helped NWBO to refine their revised SAP and FDA used that SAP to draft that guidance. In one place, the guidance favors non proportional hazard involved SAP, historical control, trial run in multiple sites, crossover etc etc as if this new guidance is specifically written for DCVaxL approval. If anyone doubts what I say, please dispute my statement with citations from that guidance or comments. I challenge. I just hope the final guidance comes out in the Federal Register tomorrow.