I identified quite clearly that the study in Latino prediabetics presented at 2013 EASD annual meeting and published in their peer reviewed journal is a level 3 study. There was also a double blinded placebo controlled study (level 1 evidence) conducted where Sucanon outperformed Glyburide, and that along with preclinical results I have referenced, were reviewed by Mexican and Peruvian authorities, resulting in approval of Sucanon sale in Mexico and approval in Peru. Note that these studies, reviews, and actions were prior to involvement of any individuals you repeatedly state are 'scammers' (Irving, Hall, etc). From a scientific standpoint, the overwhelming majority of medical treatments are not based on level 1 evidence, or even level 2 or 3 for that matter. Most is based on expert opinion developed through approved training in the profession. While controlled studies are desirable, they are not a prerequisite to established standards of medical care, as you falsely imply. I have dealt ad nauseum about the disclosure issue, the details of studies and disclosure are included below, with publicly verifiable information on previous Sucanon studies, which the FDA referred to as "substantial clinical investigations"
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 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 medications. No "obvious conflict" 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 and South Asia having some of the highest growth rates of diabetes in the world, the potential of Sucanon is enormous.
I'm pleased at the completion of the 12 week trial at ABC hospital in Mexico City to study Sucanon in combination therapy and satisfy the additional study requirements for the India regulatory application. The more Sucanon is studied, the more complete the verification of its safety and efficacy. FDA experts couldn't have said it better as these are indeed "substantial clinical investigations"
