22nd Century Group (XXII) 2018年年度报告「NYSE」.pdf

1、2018ANNUALREPORTA Plant Biotechnology Company2018 report cover pages.indd 13/19/19 5:54 PM22nd Century Group,Inc.Dear Fellow Shareholders:For 22nd Century Group,2018 was a year of investment.The Company invested considerable resources,time,and capital to accomplish the most important project in our

2、history:submission of our Premarket Tobacco Product(PMT)application and our Modified Risk Tobacco Product(MRTP)application for the Companys proprietary Very Low Nicotine Content(VLNC)cigarettes to the U.S.Food and Drug Administration(FDA).At a cost exceeding$10 million,our PMT and MRTP applications

3、actually represent many years of work.The culmination of our efforts was the December 2018 submission of more than 200,000 pages of data including research from more than 150 independent studies to the FDAs Center for Tobacco Products.With these PMT and MRTP applications,22nd Century is seeking the

4、FDAs authorization to commercialize the Companys proprietary VLNC cigarettes under the proposed brand name“VLNTM”and to advertise to consumers that VLNTM cigarettes contain 95%less nicotine as compared to the 100 leading cigarette brands in the United States.According to FDA Commissioner,Dr.Scott Go

5、ttlieb,“Cigarettes are the only legal consumer product that,when used as intended,will kill half of all long-term users.”22nd Centurys proprietary VLNC cigarettes have been designed to put an end to this madness.Following our PMT and MRTP submissions,22nd Century regulatory specialists and scientist

6、s have been in virtually constant communication with FDA regulators charged with reviewing the Companys PMT and MRTP applications.Already,we have had more than 20 conversations with the FDA on matters relating to our PMT and MRTP applications.The review process by the FDA for our applications is wel