DNDN failed, not because it wasn't approved, we know it was, but because of a lack of manufacturing capability.
Wrong.
DNDN had more capacity than it needed by mid 2011. They increased sales to somewhat over $300M and then they flatlined well below capacity. They were still bleeding cash bad and went BK in 2014. The core issue was Fools Gold and JJ the Dancing Clown. A real management team was able to take the exact same program and make it worth $1B.
They are still around by the way. Have a P3 trial for use in early prostate having results due very soon, Also talking about becoming a CDMO.