If BLA is delayed beyond end of 2019 because the FDA wants *anything* else, then the FDA is corrupt. It’s time to approve this drug. It has the potential to save/improve millions of lives with zero side effects. The fact that 800 are safely on the drug and benefiting from it, many for years, means the FDA needs to stop pussyfooting around.

Sorry about the venting but I remember NP promising BLA by end of 2018.