Iconoclast ..... GREAT post, you just said what I was "trying" to say, only MUCH better and more eloquently. I am not confident about the prospects of NDA directly after the BoM shortcoming, but I would not be surprised, and am actually somewhat optimistic.

But, yes, Don needs to remain humble, nott push publicly but remain respectful, ... and PUSH LIKE A bulldozer in the appropriate forums behind the scenes. Do not emabarrass or tell the FDA what to do. simply make your case if it is a good case, and build consensus and support among the rank and file of the academic and clinical world, and among patient advocacy groups and tools.