PharmaRoth Labs, Inc. (ROTH)

[sweetlou]

The FDA was 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 their 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).

Regarding the conflicted insider comment, as you know it is acceptable to present research provided that company relationships are disclosed. It's worth noting and was covered in my other post that the preclinical and double blinded placebo controlled study where Sucanon outperformed Glyburide was done well before Dr Rojas or FROI/ROTH ever became involved. Once again the facts do not fit your statements as any can see based on publicly verifiable information