PharmaRoth Labs, Inc. (ROTH)

[sweetlou]

You give yourself a score of 100%. That's very generous based on the proven false information posted and never corrected, as well as what is left out. The things left out are what the FDA actually said and the subject sentence of a Consumer Reports article omitted to falsely try to characterize Sucanon as the subject of an FDA warning on improperly marketed supplements while falsely and repeatedly despite correction calling the post a verbatim excerpt. That warrants a grade of 'F' for promulgating false information. The supporting information is below for any that wish to verify.


You state " FDA denied this scam" and previously"The FDA application was rejected is because it's a scam"

The first statement is a gross misrepresentation, the second statement is verifiably false. There have been so many other similar verifiably false statements posted regarding material closely related to the FDA issue, I have included it all to clarify the overall picture and include a link to the FDA letter to allow all to evaluate what the FDA actually said in context.

FDA states in the last sentence of the third paragraph in page 2 of their response letter that they did not review any of the safety data because Sucanon is not a supplement. As stated repeatedly in the first paragraph, FDA considers Sucanon a drug. FDA was also apparently impressed enough to state in the response letter that Sucanon is a drug that was subject to "substantial clinical investigations" and cite an example of the research, namely Dr. Rojas study in Latino prediabetics presented at the 2013 EASD annual meeting and published in thei EASDs peer reviewed journal.

As for the repeated misleading comment of a "ban", Sucanon was never sold in the US and cannot be sold as a supplement because the FDA considers it a drug per the food and drug act and one that had undergone "substantial clinical investigations". Sucanon would require an investigational new drug application in the US and therefore focus is on other markets where Sucanon is approved and sold (Mexico) approved but not yet sold (Canada) and in the regulatory process (India).

Despite this information being previously posted and publicly verifiable, Jayyy previously and repeatedly posted a response to the above "NOT TRUE, they just DENIED this health (and financial) scam..."

For the complete FDA letter here is the link so readers can evaluate for themselves as opposed to incomplete and misleading excerpts:

https://www.regulations.gov/#!documentDetail;D=FDA-2014-S-0023-0011

In the middle of page 2 the FDA letter states:
"Moreover, the product to which you refer in your submission appears to be a drug under the Act and thus subject to the regulatory requirements of drugs."

So the FDA says Sucanon is a drug. They further state in the letter that Sucanon has been subject to "significant clinical investigations" and reference the Sucanon study in Latino prediabetics presented at the EASD 2013 annual meeting and included in their journal. Even more evidence is listed and source attributed in my previous posts on this issue.

FDA is pretty clear when their letter is actually read in context, so much so that the so called fraud had to be manufactured by the editing and posting of a Consumer Reports article in post 4477 and many following posts to falsely indicate that Sucanon was among products whose companies were warned by FDA. Unfortunately so much misinformation posted here requires readers to consult the source information like the entire unadulterated FDA letter and postings and the real unadulterated Consumer Reports article and Sucanon studies to do actual DD.

What is also lost in the continued misleading posting about an "FDA ban" is that logically:
1. Sucanon was never sold in the US.
2. Supplements, per FDA guidance, don't need an application for sale in the US market.
3. Out of an abundance of caution, ROTH sends FDA a letter to request review of proposed sale of Sucanon as a supplement since it contains a "natural product" and is based partly on Chinese herbal medicine.
4. As above FDA says Sucanon is a drug, we have not reviewed your safety data, but Sucanon would require a new drug application, citing publicly disclosed substantial clinical investigations.
5. Now logically, if a supplement doesn't require approval and safety information was not reviewed, the only reason FDA would have to say Sucanon can't be sold as a supplement in the US is because it is a drug.
6. The above is a reasonable conclusion based on Sucanons efficacy in published studies, namely outperforming (FDA approved prescription) Glyburide in a head to head double blinded placebo controlled trial.

Now don't just take my word for it. Read the source documents. All my facts are independently and publicly verifiable and I encourage all possible DD, including checking the accuracy of any information posted here.

You then state "their "so called" trials YEARS AGO were done by a paid CONFLICTED insider/shareholder"

This statement is also verifiably false. The preclinical and double blind placebo controlled Level One study in which Sucanon outperformed glyburide in several clinical measures was in fact conducted when the product was under management of Bob Rieveley, Biotech holdings, before involvement of FROI or ROTH current individuals. In fact, the preclinical and earlier clinical results form the basis of approval by Mexican authorities in 2005.

Here is 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 that are so often criticized by Jayyy as "a sophisticated group of notorious scammers"). It is indeed strange how logic is so flawed to accuse previous individuals and studies performed long before of being a fraudulent scheme. Logically, in fact, this reasoning only proves the predisposition to a foregone conclusion of "fraudulent scheme" and the necessity of making the facts fit that false conclusion. Specifically, Dr. Rojas was in no way involved with any of the above preclinical and clinical testing, and any statement otherwise is false revisionist history and an attempt to discredit the product and previous testing with no basis.
Further, even the later clinical study in question that you refer to, received and declared compensation as a consultant of the company and published a study in 97 prediabetic Latino individuals in which 81% showed a normalized hemoglobin A1c value after 12 weeks of Sucanon treatment. These study findings were presented at the EASD 2013 annual meeting and published in their peer reviewed journal. Any knowledgeable of the medical field will note that it is permissible to published or present research as long as any possible conflicts are declared.