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Re: Jayyy post# 6737

Tuesday, 08/23/2016 2:13:32 PM

Tuesday, August 23, 2016 2:13:32 PM

Post# of 13735
As I explained many times before, contacting Compliance is optional at the discretion of Roth IF they want to get approval as a drug.

Again, as I explained many times before, the company has decided to market in countries where they have approval already, where FDA does not have jurisdiction. FDA approval would cost millions and take years, so the company has decided not to for FDA approval as a drug at this time.

Again, half the story does not tell the full story.