Here is a presentation at Yale from a few years ago in which Mann explains what he means about the hurdles to commercializing a product. Note that he has abandoned his support for the university research centers as his experience with Afrezza has shown that the barriers to entry in the biomedical field require more than a $100 million institute can muster.

Just the first 15 minutes will give you all you need to know about Mann and his philosophy. Then ask yourself, if this guy can't succeed, who can? Or is dishonesty and subtrefuge the only way to get past the FDA?

http://streaming.yale.edu/cmi2/orator/OCR/20100916/OCR20100916.html