Replies to post #9777 on PharmaRoth Labs, Inc. (ROTH)

[sweetlou]

To clarify I never said any of the things you listed in your post. What I did say and prove irrefutably is that you falsely stated that Sucanon is not a drug according to the FDA. As any can see the proof is all below and it is all publicly verifiable with the entire unedited FDA article link for any to examine for themselves.

Post 9773 correctly stated that Sucanon is a drug
You state "Not according to the FDA"
Here are FDA's actual words and a link to the FDA letter to allow all to evaluate what the FDA actually said in context. Note that FDA comments do not include "unimpressed, scam, fraud". They do refer to Sucanon as a drug under the food and drug act, a drug subject to "substantial clinical investigations" So right there your assertions are priovably false. Here is the absolute proof at length and publicly verifiable:

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 the 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).

Jayyy 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 "substantial 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. The logical fallacy is astounding because the FDA themselves clearly said that Sucanon is not a supplement. It therefore can't be in the category warned against by Consumer Reports because per the FDA Sucanon is not a supplement, it is a drug and subject to the application and evaluation requirements of investigational new drugs. 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.

[old biohf guy]

A lot of half-truths as usual.

First, the FDA did not ban Sucanon. They just did not approve an application for over-the-counter sales.

Second, Sucanon was not denied by the FDA. They just did not approve an application for over-the-couunter sales.

Third, actually, the application for over-the-counter sales was not approved only because the FDA determined that Sucanon is a drug. This is good news and bad news. Good in that it is classified as a drug, but bad because sales of Sucanon could not be sold immediately over-the-counter.

Fourth, of course no sales in Canada is not a good thing, but this is only becaue a distributor has not been set up yet in Canada.

Fifth, you say that "stock is a loser". This is a relative and meaningless term. Every stockholder surely wants the price to be higher and when India aproves Sucanon the price will surely go up. When Canagen starts to sell in India surely the price will go up. When the clinial trial results from ABC Hospital in Mexico are released surely the price will go up. The investors do not own Roth for its present sales and financial condition, but rather for the huge future potential.

Sixth, the revoked business license in Nevada is bogus as this has been reassigned to Wyoming as I understand it. Please do some unbiased research here if you can.