crescent
my weakness is that I know so little about what these regulators demand to see, but I agree with you and do NOT think a Phase 3 is necessary which would take years to accomplish probably even if it were a confirmatory trial, way longer than a Phase 4 which would allow for use to the patient.
I tend to think that the 58 scientists had enough PROOF and on top of that the OLE data was considered very good.
I don't think 4% or 35% odds are in the ball park at all.....and if we get some indication that clock stop one has been completed it's like betting on making a 8 or 9 on the craps table.Damn good, certainly better than a 4