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22nd Century Group Inc. (NYSEMKT:XXII) In Discussion With FDA Over Product Approval

22nd Century Group Inc. (NYSEMKT:XXII)

22nd Century Group Inc. (NYSEMKT:XXII)

Shares of 22nd Century Group Inc. (NYSEMKT:XXII) were unchanged in Monday’s trading session as the company continued to push for regulatory approval of its smoking cessation product X-22. The company is also fresh from inking a partnership with the University of Virginia for the use of Industrial Hemp to clean up and reclaim polluted lands.

22nd Century Group Inc. (NYSEMKT:XXII) is currently trading in a $1.72-$2.07 trading range after a pull-back from highs of $2 per share last week. Immediate support on the stock is at $1.40.

The plant biotechnology company boasts of a proprietary technology that enables the adjusting of levels of nicotine and other nicotinic alkaloids in tobacco plants through genetic engineering. The company also develops smoking cessation products.

FDA Meeting

22nd Century Group Inc. (NYSEMKT:XXII) recently participated in a meeting with a multi discipline review team at the Centre for Drug Evaluation and Research. The meeting sought to consider whether 22nd Century Group’ X-22 smoking product can be approved for use in helping people quit smoking. The company has since been asked to carry out two parallel Phase 3 clinical trials, to prove whether the product can result in a robust quit rate in smoking, compared to existing cessation products.

“We look forward to working collaboratively and closely with the FDA during 2017 regarding the approval of important aspects of the two parallel, Phase III clinical trials on X-22 that we intend to commence in the first half of 2018,” said CEO, Henry Sicignano III.

Trials will begin as soon as 22nd Century Group gets clarification on whether to use its own funds for the trials or source funds from third parties.

Environmental Cleanup

Separately, 22nd Century Group Inc. (NYSEMKT:XXII) and the University of Virginia plan to use a variety of industrial hemp to clean abandoned mines as well as polluted landscapes. The biotechnology company has already developed proprietary hemp plants that the two plan to use in phytoremediation. The hemp plants are designed to absorb toxins, metals as well as soil contaminants.

22nd Century Group Inc. (NYSEMKT:XXII) Vice President for plant biotechnology, Dr. Paul Rushton, expects the cleanup process to validate the company’s technology in addition to opening up new lucrative markets.

“We are enthusiastic about the prospect of applying our biotechnology expertise to a challenging environmental problem,” said Dr. Rushton.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

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About the author: Monica has an undergraduate degree in Accounting and an MBA she earned – with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.

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Monica has an undergraduate degree in Accounting and an MBA she earned - with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.

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