NorthWest Biotherapeutics Inc (NWBO)

[Maverick0408]

I agree with your perspective and I can confirm this to be the case with FDA. I have gotten multiple medical device through FDA 510k approvals. You have to provide manufacturing site address and certifications as part of your FDA application submission. Without with, the application will be deemed incomplete.

Having said that, I don’t quite understand the intricacies between specials manufacturing certification and commercial manufacturing certification as it applies to cell therapies..,.and whether specials manufacturing certifications can be used in MAA applications to get commercial manufacturing certifications in parallel.