22nd Century Provided with Written Feedback from FDA on the Company’s Modified Risk Tobacco Product Application
February 28 2017 - 6:59AM
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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170228005123/en/
Investor Relations:IRTH CommunicationsAndrew Haag,
866-976-4784xxii@irthcommunications.com
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