There is a HUGE difference between "Doing the best
Post# of 151605

In 2020, the best "they can do" has not been good enough. Inexperience, lack of connections, or incompetence- call it what you want, but to not have a BLA filed now is ridiculous. I know people like to blame the FDA, but part of the job is understanding how to navigate the FDA process and putting the right people in place to build relationships that help the business.

