22nd Century Group Inc (XXII)

[Grape Ape]

LOL. Just reading old posts. Below is post #4 from 2011. Funny, it mentions FDA approval in 2013. Wow. Just a little off, I'd say....


Clinical Pathway

The Company is conducting a Phase II-B trial in 2011 and plans to conduct two larger and concurrent Phase III trials in 2012. The FDA-approval process for its X-22 smoking cessation aid is expected to be completed by 22nd Century and upon such approval launch X-22 in the U.S. market in early 2013 (as a prescription), and in other top smoking cessation markets thereafter. The Tobacco Control Act provides that products for smoking cessation, such as X-22, be considered for ‘‘Fast Track’’ designation by the FDA. The Fast Track programs of the FDA are intended to facilitate development and expedite review of drugs to treat serious and life-threatening conditions so that an approved product can reach the market expeditiously. 22nd Century expects that X-22 will qualify for Fast Track designation.