NorthWest Biotherapeutics Inc (NWBO)

[meirluc]

If you were the FDA, would you approve NWBO's MAA that does not
include the validation of EDEN's automatic manufacturing capacity?

I believe that the MHRA would approve but I question that the FDA would
follow because the demand in the USA would not be easily met by the manual
manufacturing capacity.

However, I admit that inclusion of the EDEN system is only one of several possible
reasons for the unexpected delay of the MAA submission to the MHRA that
was thankfully resolved after NWBO overcame that delay.

Can others on this MB think of alternative reasons for the MAA submission delay
that after being resolved, allowed the consultants to introduce an improved
section into the MAA, that greatly improved the quality of the application for
other regulators as well?