Contrary to the claim that the company avoided any scrutiny for Sucanon as a drug, the FDA in their own words stated that Sucanon has been the subject of "substantial clinical investigations". To expand further on the FDAs response, the letter stated it considered Sucanon a drug per the food and drug act, and further, that Sucanon was the subject of "substantial clinical investigations" and would need to submit an investigational drug application to the compliance office before sale in the US. Here is a brief review of some of the "substantial clinical investigations" on Sucanon:
Preclinical in vitro tests of Sucanon (then diab2) in rat muscle showed an up regulation of insulin receptors
Sucanon outperformed biguanides (Metformin) and sulfonylureas (Glucotrol, Micronase, Amaryl) in rat models
Pharmacokinetics showed dose response relationship, peak response 2-4 hours, no effect by 10 hours
Toxicity: none at dosing 2000x therapeutic levels in dogs and rats with therapeutic index > 10,000, no carcinogenicity, teratogenicity, or mutagenicity in mice
Clinical studies: randomized double blind placebo controlled study in 370 adult type 2 diabetics , 6 months (1 month screening, 4 months treatment, 1 month post treatment) Sucanon outperformed Glyburide in control of fasting blood sugar levels, urinary glucose excretion, and glucose tolerance testing
(All above results done under management of Bob Rieveley, Biotech holdings, before involvement of FROI or ROTH current individuals)
Finally Dr Rojas study presented at EASD annual meeting 2013 in Barcelona Spain: 97 pre diabetic Latino adult patients (HbA1C 5.7 to 6.2) 12 weeks with normalization of HbA1C (below 5.7) in 81% of study population and decrease in weight and visceral body fat, in contrast to weight gain in alternative oral diabetes medications. No "obvious conflict" exists,contrary to your accusations, of the researcher acting as a consultant to ROTH since any reputable professional organization allows researchers to present results at meetings when declaring a financial relationship or consultancy regarding the company or product.
The science is in fact done right, publicly verifiable and speaks for itself. The results of Sucanon testing, in addition to the risks of alternative treatments make Sucanon, IMO, an excellent first line choice for pre diabetic and non insulin dependent diabetics due to Sucanon's efficacy and safety. That is the reason I am involved as a shareholder. If this information is effectively communicated to prescribers and the burgeoning diabetic populations throughout the world (50% of population diabetic or prediabetic in USA alone) the potential of Sucanon is enormous.
I'm looking forward to the results of the 12 week trial in Mexico to satisfy the India regulatory application. The more Sucanon is studied, the more complete the verification of its safety and efficacy. FDA experts could'nt have said it better as these are indeed "substantial clinical investigations"
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