PharmaRoth Labs, Inc. (ROTH)

[sweetlou]

I appreciate your question about my opinion. Much more important than my opinion is what the FDA actually said. Much of my work as a physician involves not only "fixing" but also explaining the scientific literature in an understandable way such that patients can use that information to make the appropriate treatment decisions. I approach this forum in the same way. That is why I present my evidence and logic with publicly verifiable information (like the FDA letter) foremost followed by my conclusions or opinion.

Here is what the FDA words actually say per the link provided.

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 appears to be 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. For anyone who wishes to review, 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.

If one reads the entire FDA letter and context, then 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.

Is "appears to be a drug" the same as "is a drug"? FDA treated Sucanon as a drug because it needs a new drug application. As always, all facts are publicly verifiable. Read the source documents and judge for yourself.