Wednesday, June 14, 2017 9:24:32 AM
No other application is required by Roth. The FDA invited Roth to apply for approval as a drug. This process is time consuming and expensive, so Roth made a busienss decision to sell and market in Mexico, Canada and India where the FDA does not have jurisdiction.
Sucanon is approved in Mexico and Canada with ongoing sales in Mexico. Hopefully soon India will approve and sales will be through Canagen.
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