Home CannaBusiness 22nd Century Provided with Written Feedback from FDA on the Company’s Modified Risk Tobacco Product Application

22nd Century Provided with Written Feedback from FDA on the Company’s Modified Risk Tobacco Product Application

0
0

CLARENCE, N.Y.–(BUSINESS WIRE)–22nd Century Group, Inc. (NYSE MKT: XXII), a plant biotechnology company that is focused on reducing the harm caused by smoking, announced today that the Company has received written feedback from the Center for Tobacco Products (CTP) of the U.S. Food and Drug Administration (FDA) on the Company’s “BRAND A” Modified Risk Tobacco Product (MRTP) application. 22nd Century received feedback from the FDA in conjunction with the Company’s withdrawal of its MRTP application in order to file an even more expansive and robust MRTP application that will include additional scientific data and information from already completed clinical studies on the Company’s Very Low Nicotine (VLN) tobacco cigarettes.

The MRTP application for BRAND A requests that CTP allow 22nd Century to be able to state as truthful and accurate in BRAND A packaging and advertising that the Company’s proprietary VLN cigarettes reduce smokers’ exposure to nicotine because the Company’s proprietary VLN tobacco contains 95% less nicotine than the tobacco contained in conventional tobacco cigarettes. The Company’s keystone technology is its ability to grow proprietary VLN tobacco that contains up to 95% less nicotine than conventional tobacco plants.

In response to the CTP’s clarifying guidance, the Company intends to bifurcate its combined MRTP application into a separate Premarket Tobacco Product (PMT) application and a separate MRTP application for BRAND A to enjoy the benefit of the CTP/FDA’s shorter review period for PMT applications as compared to MRTP applications. In response to the FDA’s request, 22nd Century’s revised MRTP application will also include additional scientific data and information from already completed clinical studies on the Company’s VLN tobacco cigarettes. The Company anticipates filing its more expansive and robust PMT application and MRTP application later this year.

“We are encouraged by CTP/FDA’s feedback on our MRTP application and we look forward to working cooperatively with the FDA to obtain the Agency’s approval to market BRAND A as an over-the-counter, modified risk tobacco product that significantly reduces smokers’ exposure to nicotine,” explained Henry Sicignano, III, President and CEO of 22nd Century Group.

About 22nd Century Group, Inc.

22nd Century is a plant biotechnology company focused on technology which allows it to increase or decrease the level of nicotine in tobacco plants and the level of cannabinoids in cannabis plants through genetic engineering and plant breeding. The Company’s primary mission is to reduce the harm caused by smoking. 22nd Century currently owns or exclusively controls more than 200 issued patents and more than 50 pending patent applications around the world. Visit www.xxiicentury.com for more information.

Cautionary Note Regarding Forward-Looking Statements: This press release contains forward-looking information, including all statements that are not statements of historical fact regarding the intent, belief or current expectations of 22nd Century Group, Inc., its directors or its officers with respect to the contents of this press release, including but not limited to our future revenue expectations. The words “may,” “would,” “will,” “expect,” “estimate,” “anticipate,” “believe,” “intend” and similar expressions and variations thereof are intended to identify forward-looking statements. We cannot guarantee future results, levels of activity or performance. You should not place undue reliance on these forward-looking statements, which speak only as of the date that they were made. These cautionary statements should be considered with any written or oral forward-looking statements that we may issue in the future. Except as required by applicable law, including the securities laws of the United States, we do not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events or circumstances, or to reflect the occurrence of unanticipated events. You should carefully review and consider the various disclosures made by us in our annual report on Form 10-K for the fiscal year ended December 31, 2015, filed on February 18, 2016, including the section entitled “Risk Factors,” and our other reports filed with the U.S Securities and Exchange Commission which attempt to advise interested parties of the risks and factors that may affect our business, financial condition, results of operation and cash flows. If one or more of these risks or uncertainties materialize, or if the underlying assumptions prove incorrect, our actual results may vary materially from those expected or projected.

Contacts

Investor Relations:
IRTH Communications
Andrew Haag, 866-976-4784
xxii@irthcommunications.com

Source: New feed

LEAVE YOUR COMMENT

Your email address will not be published. Required fields are marked *