"IMHO...there will not be any VLN designation for at least 4 years when the FDA completes its study."
IMO this study is to determine to regulate nicotine in all cigarettes. This does NOT mean that XXII will not get approval to sell these cigarettes in the US before the trials are completed. They are filing the applications to do so this upcoming quarter. This approval shouldn't take 4 years because I'm sure this was discussed in the meeting with the FDA back in June.
FDA Meeting
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) requested to have a meeting with 22nd Century to discuss the company’s proprietary products. 22nd Century agreed to meet with the FDA on June 17, 2013.
Goodrich Tobacco has developed two proprietary modified risk cigarettes, referred to as BRAND A and BRAND B, which the company believes are less harmful than conventional cigarettes. The company is in the process of preparing two modified risk applications to be filed with the FDA in accordance with FDA guidelines to seek FDA authorization to market BRAND A and BRAND B as modified risk cigarettes. BRAND A is a very low nicotine (VLN) cigarette containing approximately 95 percent less nicotine than leading brands. BRAND B is a low-tar cigarette with a relatively high nicotine content. The company expects to file one application by the end of 2013 and another in 2014.