SEC Comment Letter for 22nd Century Group, Inc. (XXII) (CIK 0001347858) (XXII) — Aug 29, 2011
22nd Century Group, Inc. (XXII) (CIK 0001347858)
Date: Aug. 29, 2011 · CIK: 0001347858 · Accession: 0000000000-11-051722
AI Filing Summary & Sentiment
Reasoning
File numbers found in text: 333-173420
Referenced dates: August 22, 2011
Letter
August 29, 2011 Via E-mail Joseph Pandolifino Chief Executive Officer 22nd Century Group, Inc. 8201 Main Street, Suite 6 Williamsville, NY 14221 Re: 22nd Century Group, Inc. Amendment No. 5 to Registra tion Statement on Form S-1 Filed August 26, 2011 File No. 333-173420
Dear Mr. Pandolifino: We have reviewed your responses to the co mments in our letter dated August 22, 2011 and have the following additional comments. All page numbers below correspond to the marked version of your filing.
General
1. With a view to revised disclosure, please ex plain to us any reasons the FDA gave for denying fast-track designation for X-22.
Risk Factors, page 9
Risks Related to Regulatory Approvals and Insurance Reimbursement, page 14 If we fail to obtain FDA and foreign regulatory approvals of X-22, page 14
2. We note your disclosure on page 14 that “if you are not able to have X-22 qualify for Fast Track designation by the FDA, [you] will not recei ve the benefit of a priority review from the FDA” on page 14. Please expand this risk factor to disclose that you “previously submitted a request for Fast Track designation and on August 18, 2011, the FDA informed [you] that designation of X-22 as a Fast Tract Product [coul d not] be granted at this time, but, if [you] desire further consid eration, [you] should submit a new request for Fast Track designation.”
3. Please revise to provide a separate risk factor addressing how your business will be impacted if you are unable to receive Fast Track designation and a priority review of X- 22 from the FDA, including what the effects may be on the timing and costs of obtaining
Joseph Pandolifino 22nd Century Group, Inc. August 29, 2011 Page 2
FDA approval for X-2 and its impact on your financial condition. This disclosure will help investors better understand this risk. Principal and Selling Shareholders, page 28
Selling Shareholders’ Table, page 29
4. Please revise footnote 14 to identify the indi vidual or individual s who have voting or investment power with respect to the shares held by Gibralt US, Inc. Management’s Discussion and Analysis of Fina ncial Condition and Results of Operation, page
5. We note your revision to the firs t sentence in the third paragra ph of this section. Please delete this sentence as this is not a quarterl y report. We also note that the PSLRA safe harbor for forward-looking statements in Section 27A of the S ecurities Act is not applicable to you.
6. We note your response to our pr ior comment two and reissue in part. Please revise to include disclosure regarding the annual “cl ean-up” provision that requires you to repay all principal amounts outstandi ng and disclosure that you have not complied with the “clean-up” provision. In addition, please revise to add a risk factor that addresses your failure to comply with the “cl ean-up” provision or tell us w hy this is not necessary.
7. We note your revision on page F-28 regard ing the promissory note dated June 30, 2011 that is due on August 30, 2011. Please revise to add disclosure here regarding this note or advise.
Please contact Sonia Bednarowski at (202) 551-3666 or me at (202) 551-3859 with any questions. Sincerely, /s/ John Dana Brown John Dana Brown Attorney-Advisor cc: Via E-mail
Patrick G. Quick Foley & Lardner LLP
Show Raw Text
August 29, 2011
Via E-mail
Joseph Pandolifino Chief Executive Officer 22nd Century Group, Inc. 8201 Main Street, Suite 6 Williamsville, NY 14221
Re: 22nd Century Group, Inc.
Amendment No. 5 to Registra tion Statement on Form S-1
Filed August 26, 2011
File No. 333-173420
Dear Mr. Pandolifino:
We have reviewed your responses to the co mments in our letter dated August 22, 2011
and have the following additional comments. All page numbers below correspond to the marked version of your filing.
General
1. With a view to revised disclosure, please ex plain to us any reasons the FDA gave for
denying fast-track designation for X-22.
Risk Factors, page 9
Risks Related to Regulatory Approvals and Insurance Reimbursement, page 14
If we fail to obtain FDA and foreign regulatory approvals of X-22, page 14
2. We note your disclosure on page 14 that “if you are not able to have X-22 qualify for Fast
Track designation by the FDA, [you] will not recei ve the benefit of a priority review from
the FDA” on page 14. Please expand this risk factor to disclose that you “previously
submitted a request for Fast Track designation and on August 18, 2011, the FDA informed [you] that designation of X-22 as a Fast Tract Product [coul d not] be granted at
this time, but, if [you] desire further consid eration, [you] should submit a new request for
Fast Track designation.”
3. Please revise to provide a separate risk factor addressing how your business will be
impacted if you are unable to receive Fast Track designation and a priority review of X-
22 from the FDA, including what the effects may be on the timing and costs of obtaining
Joseph Pandolifino 22nd Century Group, Inc. August 29, 2011 Page 2
FDA approval for X-2 and its impact on your financial condition. This disclosure will
help investors better understand this risk.
Principal and Selling Shareholders, page 28
Selling Shareholders’ Table, page 29
4. Please revise footnote 14 to identify the indi vidual or individual s who have voting or
investment power with respect to the shares held by Gibralt US, Inc.
Management’s Discussion and Analysis of Fina ncial Condition and Results of Operation, page
58
5. We note your revision to the firs t sentence in the third paragra ph of this section. Please
delete this sentence as this is not a quarterl y report. We also note that the PSLRA safe
harbor for forward-looking statements in Section 27A of the S ecurities Act is not
applicable to you.
6. We note your response to our pr ior comment two and reissue in part. Please revise to
include disclosure regarding the annual “cl ean-up” provision that requires you to repay
all principal amounts outstandi ng and disclosure that you have not complied with the
“clean-up” provision. In addition, please revise to add a risk factor that addresses your
failure to comply with the “cl ean-up” provision or tell us w hy this is not necessary.
7. We note your revision on page F-28 regard ing the promissory note dated June 30, 2011
that is due on August 30, 2011. Please revise to add disclosure here regarding this note
or advise.
Please contact Sonia Bednarowski at (202) 551-3666 or me at (202) 551-3859 with any
questions.
Sincerely,
/s/ John Dana Brown John Dana Brown
Attorney-Advisor
cc: Via E-mail
Patrick G. Quick Foley & Lardner LLP