You keep saying they will file for a NDA for part , use effiacy from safety or etc.......not my understanding. And the reason for a new efficacy trial.
Please write to Mr Donenburg......I posted his response when i asked if they could file for part i.e. safety
The answer i received was NO
FDA agreement  proven efficacy  proven safety PERIOD
not withstanding the possibility that they will not be able to negotiate with FDA now be able to.......I hope so.