Nader is a good player, IMO. I don't know the rules. If you don't know either that's fine. No need to say it. I understand.

Here we need a someone who needs to:
a) understand FDA guidelines, and avoid pitfalls at any cost.
b) Lay out a solid plan, and plan for Risks
c) Execute.

a) of the above need someone experience in all FDA rules, and their procedures.