Havasu: "Has anyone else ever bulldozed the FDA i

Havasu: "Has anyone else ever bulldozed the FDA into an EIND not only without any preclinical studies, but even in the face of the FDA scientists' belief that the drug has no relevance to the disease?"

I'm very interested in what you are referring to here. Can you provide more information and/or a link so I can learn about it? Thanks in advance, Ganesha