Q: This revenue source is dependent on FDA approval. How is your relationship with the FDA?
Henry: In June of this year, the Center for Tobacco Products of the FDA invited us to their headquarters in Maryland for what they call a listening session. They wanted to listen and learn about our technology. We spent 2 hours talking to the FDA about our technology and the potential public health benefits of our products. One of the questions that the FDA had was that if they were to mandate lower nicotine cigarettes for all cigarette brands in the United States, could we do that, and how long would it take? The Tobacco Control Act empowers the FDA to force the utilization of technology across all cigarettes in the United States. So if they wanted to mandate lower nicotine cigarettes, the technology exists. We told them it would take approximately 2 years to genetically engineer all the tobacco varieties that are grown and used in US cigarettes. We conveyed to the FDA at our meeting that we were going to file a modified risk application for our VLN cigarette (BRAND A) and the FDA seemed very open to this and inquired when we would file the application. Two months later, the FDA put out to bid a contract for very low nicotine tobacco containing 0.30 mg nicotine per gram of tobacco. No other company in the world could fulfill this order because we are the only company in the world that has tobacco with those extremely low nicotine levels. Therefore, we won the contract which was approximately $230,000
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