Ofcourse IR does know as much as any of us but it does boost a hell of a lot of confidence. Why say this if you are not sure the drug will be approved
As many here might knw from direct experience or association small high tech organizations will be populated w/staff who each have their own version of the truth. Some, like IR, are expected to be obtuse. They will never intentionally mislead, unless they have a death wish.
Things can go wrong or "POP UP" during final analysis which make everyone stop breathing for a few until they reset. There probably is a scheduled release date-time. The level of detail above minimums is what may be taking time, setting baseline. (ALL IMO) It is already soup, just the last seasoning being considered.
They're confident, as are all biotechs who believe in their pipeline. Correct, no one can be sure. IR is not saying they can take it to market for these indications, but that they can take it without partners. The latter was the point.