NorthWest Biotherapeutics Inc (NWBO)

[Maverick0408]

“No RA I know of has a rule that capacity must be of any size in order for the drug to be approved. For the FDA this is by law. “

I agree on this as well. Worked on several successful class II and III medical device approvals across US and Europe with our team over the years and never had to deal with volume requirements. And Class III medical device approvals are just as stringent as the one NWBO is dealing with. It’s all about quality, standards, and the compliance of the manufacturing facility.