NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

It’s not about the initial design but the policies at FDA that allow for the recognition of changes during the course of initiating new technologies and long trials. The point is that people who suggest the rules that applied when the trial launched do not understand that the entire regulatory process and guidance has changed. Hence it’s NOT actually odd that they addressed that change in a revised SAP. It’s a change in law and mindset at FDA, not about the initial design.