"The right way to do things" according to your "FDA guide" is not applicable to Sucanon because it is not under FDA consideration currently. Sucanon was submitted as a neutraceutical and the FDA came back that it is a drug and would need review as such before approval in the USA.
What is missing logically from the posted information is that the study process listed would leave out preclinical testing in vitro and in animals for initial efficacy and safety. Your posted "right way to do things" would first test in humans without undergoing the above preclinicals. That approach would be reckless and potentially harmful lacking appropriate knowledge about the mechanism of action, safety as characterized by therapeutic index, dose response relationship, among other issues studied for Sucanon in the preclinical process I outlined in the "sticky post" above.
In other words, Sucanon was studied in the lab and animals first in the preclinical process. If it had not shown efficacy and safety there (then known as diab 2) no reason would exist to move on to human studies. Sucanon was very successful in preclinical and follow on human studies that led to approvals for sale in China (as diab2) and in Mexico, where it is sold without a prescription, and also had approval in Peru previously.
Interestingly, the randomized double blinded placebo controlled study in 370 patients, 6 months where Sucanon outperformed Glyburide in head to head evaluation, contains most of the elements outlined in phase 2 and 3 testing. Phase 4 or post clinical follow up is not necessary in all cases even with the FDA unless they identify specific follow up requirements. Nevertheless, Sucanon continues to be studied as in the 12week study in 97 prediabetics with an 81% rate of normalized HbA1C following the treatment period, presented at EASD annual meeting 2013. The more Sucanon is studied and used, the more post clinical follow up is collected so any even previously unknown side effects could be identified. The fact that Sucanon has been out there for 14 years, albeit poorly marketed is even more convincing that any underlying safety issues would have had plenty of time to be identified.
The thing is, the science shows Sucanon works, and people who take it verify that it works, for example the 2007 endorsement by the president of regional diabetes organization "Club Dulce Vida" who reported on his personal experience with the use of Sucanon in his diabetes treatment.
