I think Respert has the right idea. I've been POC

I think Respert has the right idea. I've been POC on the industry side with 2 large US bureaucracies for a little under 3 decades. Large bureaucracies are cumbersome and rule laden monstrosities. They are not well designed to be very innovative procedurally and they are constantly besieged by hucksters trying to sell their new form a "snake oil" to a huge market. A bureaucrat just trying to do their 20 and land a fat cat industry job survives by following the rules and not sticking their neck out on some "snake oil" that may not work and may have currently unknown safety issues. I can also tell you kicking sand in the face of a bureaucracy is a really bad idea. Some here just can't stop beating that very dead horse. It's over, it's done, we brought on our own issues with them. That some of it from the FDA appears purposeful and punitive is possibly true, but you continue to piss off someone in power you should not be surprised when the very human bureaucrat on the other side smacks you in the mouth. Making a common comparison to a poker game they not only have the better hand, they control all the cards. They tend to absolutely despise obvious hucksters like Nader. They don't want their careers to be soiled by such people and their coworkers and leaders understand completely. They have a certain way things need to be done and tons of paperwork all requiring exactness. I have worked with people who have graduate degrees in government paperwork. Your common bureaucrat has little to no authority to be flexible, or innovative. The way it is explained in the manual is the way it will be done today and tomorrow until the manual changes, or someone higher up signs off on taking the blame for it if it goes bad. Expecting a large bureaucracy to act like an innovative business is naive in the extreme.

The above said I have found your standard bureaucrat to be someone trying to do the right thing and in most cases quite competent. Generally the problem is the rules, not the individual; and the rules, though quite cumbersome, are necessary to maintain order within a very large system.

CYDY under Nader is the exact model of what bureaucrats hate. Dr. JL's description of the company under Nader is all you should need to know to understand many of the reactions from the FDA.

The good news is a very competent Dr. JL is at the helm and we appear to have a damn interesting molecule in our control. Money problems to be sure. I don't expect much this year, but I believe we are now on a path that will shine a very bright light on an extremely interesting molecule.