Oh baloney, they are clearly set, with the various publicized applications already made and some approved to have already or shortly to have submitted their full BLA application. The PIP and Manufacturing applications are key, core pieces of any marketing approval application and they’ve done the presentation, so the fact is, they have their analysis done to make the application as well. It’s very possible it is already pending, but if they are waiting for something else, which I do not think is likely, then that is fine because they are well on their way. Anything they would be waiting on would no doubt be a critical part of their success.
Some do hate success when they’ve been booing and booing for years. But that’s not going to have any impact on their success, at all.