PharmaRoth Labs, Inc. (ROTH)

[finishsuper]

The FDA press release

In a former life, I worked filing a lot of applications with government agencies (mainly FDA and USDA). From personal experience, I can tell you that our government is not very efficient, and is mired in red tape.

The fact that they received back information from the FDA with specifics about Sucanon meeting the criteria of a "drug" in the US, is huge. The normal process usually entails having to meet all of the filing requirements, and only at the time of awaiting "final approval", do they come out with "Oh, wait. This should have been treated as a drug, not as a neutraceutical", and the company or individual having to start all over at square one again (process and cost).

Having clear definition of "drug", ROTH can now proceed down the correct path towards compliance and acceptance, while getting real time, real world results from the OTC sales in Latin and South America.

Perhaps it's a blessing in disguise, so long as we don't lose the forest because a tree or 2 gets in the way.

Best.