NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

Umibe5690,

I agree that regulators won't "approve" the SAP ahead of time but they certainly will have been asked for input from a preliminary presentation to avoid any unnecessary further delays. If they have questions about what or how something is going to be presented then getting that worked out before a final presentation is important. The orphan status of this disease indication gives NWBO access to this type of interaction.

The other issue is that this SAP will include the necessary documentation to validate not only the need for an exception to an adequate and well controlled trial (easy and already determined) but also the documentation to validate the new assessment measures (new and not so easy). That is where the rubber hits the road and where questions and input are most likely to occur. That is the benefit of working on an orphan disease with regulator input but this can lead to expected and unexpected delays. Best wishes.