Replies to post #11025 on PharmaRoth Labs, Inc. (ROTH)

[sweetlou]

You state: “LAUGHABLE- this snake oil being compared to an FDA approved drug”
Sucanon has already been compared to and outperformed FDA approved Glyburide in a double blinded placebo controlled study, 370 patients 6 months duration. Details are below. All are encouraged to evaluate what the science says. It’s all publicly available and verifiable.

Here is what we already know about Sucanon so far in advance of the trial at ABC hospital in Mexico City for which we are awaiting results...
The summaries of studies below come from 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 commonly seen with alternative oral diabetes medications

[old biohf guy]

Yes, Metformin is FDA approved and Sucanon is not. That being said, test results for Sucanon indicate similar blood sugar lowering but with no side effects.

Generally the word "banned" would be applied to a product that is know to be harmful or which has been marketed illegally. Sucanon is not either of these - it has never been marketed in the US and there is nothing harmful about the product. So I maintain that the word "banned" is not a proper description.

So, what would Sucanon be worth if it was FDA approved? How about approval in India - what would that be worth? How about ABC Mexico City positive clinical trial results? What would that be worth? This is why investors own Roth.