If you consider on Dec CC . Nader was asked specifically since BLA was not going to get filed in December how confident he was it will get filed in January. His response was unequivocal it would get done in Jan. Too many failed assertions / promises. You should under promise and over deliver and that will instill confidence. And when you occasionally miss your target get in front of it ASAP... continued missed deadlines instills doubt. It is a shame because this drug has potential