JL
The Regulatory nonsense is what got us to where we are today. The SPA debacle is 100% Politics and Regulation...not at all trying to beat the FDA at their own game on their field.
What I've learned, dealing with the FDA, they are extremely arbitrary in all their dealings...especially when it comes to view of small companies and stakeholder. If this makes it to Court we need these examples.
I also think it's imperative we document the science on the EPADI CP, Woodcock has to deny it based on a scientific and regulatory reason...she has neither.
I'm willing to take your lead, what do you need from me?
BB