NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

exwannabe,

Exactly!; ). FDA does not “approve” an SAP prior to an actual marketing approval decision, it “accepts” it as provisional with further review during application consideration. Not so with the Europeans. They basically “approve” or reject the SAP ahead of time because manufacturing readiness needs to be in place before the application is presented. In the US the manufacturing can be completed during the application review time. This means more investment up front in Europe for approval but with much greater assurance that there are no issues surrounding the SAP which are the measures used to demonstrate efficacy.
Thank you for pointing out the strong rational for seeking approval in the UK first with a technology that threatens the status quo. Big pharma and others have influence in the US regulatory process. This puts them in position to affect regulator decisions which are more subjective purposely for what could otherwise be for good reasons. By not “approving” a SAP prior to actual submission for approval the door is left open for opinions to be influenced by outside influence. So… thank you for taking the time to bring this all to the board’s attention with your input on the handling of SAPs by FDA and allowing all to see how Linda had this all thought out long ago; ). Best wishes.