Accelerated approval , various titles Yes I agree with niteable. It was clearky stated they are working with FDA, including a thiurough document that was assisted by existing pharma colaborators.
essentialy they have indicated the phase 3 trials are to be designed as smooth transition, directly to product approval.
That was the context of the conversation(s).
exact words, im sure noteable can find.
Repeating myself, one reason things are taking as long as they are.
The MBc process for example, involves Onc, FDA & other pharma.
The Panc involves Onc, CGAR, FDA & Roche.
all with various rules, laws etc etc.
when this unfolds, the outcomes will be made clear.