DNDN – All of your arguments have merit—up to a point. But I prefer the simpler explanation that time is not of the essence in submitting the BLA because DNDN does not expect approval from the exiting data package.
Incidentally, my view won’t change even if the first section of the BLA is submitted tomorrow. The BLA timeline to date has been wholly inconsistent with the notion that DNDN thinks Provenge is a blockbuster-in-waiting with a compelling data package.