Replies to post #9833 on PharmaRoth Labs, Inc. (ROTH)

[sweetlou]

I never claimed to know when trial results are coming out. They will come out when completed and there is an announcement. Despite your false claim in post 9757 that I am an Internet insider trying to misdirect facts, my only claims are listed below and they are all verifiable. It is also verifiable that you falsely stated that
1. Irving lied to all shareholders
2. Irving said results will be right after the trial
3. The supposed letters to SEC and FINRA are without any evidence
4. When Sucanon was correctly referred to as a drug, falsely stated "Not according to the FDA"

I note that none of the above was addressed, yet I am told to give an exact date when the study will be released (a change of subject). Evidence is all below:

You state "I have written to SEC and FINRA." It seems reasonable, then, that one would post the letter and response. There were several similar posts in the past of questionable validity at best. For example, stating Canagen was fake because the email bounced back. I emailed Canagen on the posted link and it worked just fine. There was the supposed communication with EASD that "they knew nothing about the press release announcing the presentation of Sucanon study results in prediabetics at the 2013 annual EASD meeting and publication of the abstract in their peer reviewed journal Diabetologica. Of course EASD does not review the press release as it is not their role, but they most certainly did review and select Dr. Rojas' presentation for the meeting and subsequent publication. Bottom line is if some correspondence is alleged then post it. I post complete and unedited publicly verifiable information in support of every fact I cite regarding this company, as an example the complete FDA letter and the complete Consumer Reports article that is inapplicable to Sucanon. Before trying the previous tactic that "my conversation is privileged", logically, and legally, one can't cite a privileged conversation as evidence and then refuse to disclose it. If cited it must be backed up or not mentioned at all.

You state "Mike Irving lied to all shareholders saying that is was done and results would have been right after the trial."
I am a shareholder and Irving did not ever represent to me that the results would be right after the trial. So the statement that Irving lied to all shareholders is verifiably false. If you indeed have proof of a conversation with or correspondence with Irving where this is stated then post an email, letter, or recording of a conversation where that occurred. Better yet also send it to SEC and FINRA.

You state "Marks Beware--THIS IS ALL A SCAM as reflected in the FDA DENIAL"
Any can refer to the entire FDA letter below and nowhere will one find the word "scam". 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.