Was thinking more about this. 1) FDA wants this drug 2) FDA just found out that pain rebound numbers for past clinical trials for other approved drugs were almost certainly pumped up bc patients were un-blinded when the "buzz" or "high" went away 3) FDA found out with 181 trial that there is a higher post treatment placebo effect than they knew for painkillers for patients that are truly blinded 4) FDA will now do every thing they can to help NKTR with a phase 3 design that accounts for this hiccup.
The design for phase 3 will be unique but they will figure out a way that with similar positive results in phase 3, the design will pass the endpoints with flying colors. Very little doubt here, IMO.
They will definitely be in the boat. This is fast tracked for a reason. FDA and medical community are beside themselves, with no good answers, for the OVER, 35,000 folks we lose a year to pain killer overdoes. They/we need a silver bullet. More eyes on 181 than most realize.