XXII news...
Co states, "The Company is very pleased with the productive and encouraging communication it received from the FDA. Though the Company is only requesting an MRTP marketing order that will allow 22nd Century to disclose that BRAND A reduces smokers' exposure to nicotine, the FDA has requested more information related to the independent clinical studies on the Company's Very Low Nicotine tobacco that focused on smoking cessation and harm reduction objectives... In response to the FDA's requests, and in conjunction with additional clarifying guidance, the Company has withdrawn its existing filings in order to file even more expansive and robust MRTPAs and PMTAs for BRAND A that will include additional scientific data and information from already completed clinical studies on the Company's Very Low Nicotine tobacco cigarettes, in addition to smoking cessation research. In order to help further expedite the FDA review process, the Company also intends to bifurcate its application into separate PMTAs and MRTPAs for BRAND A to enjoy the benefit of the FDA's shorter review timing for PMTAs as compared to MRTPAs."Copyright (C) 2010 Briefing.co
