SEC Comment Letter for Tonix Pharmaceuticals Holding Corp. (TNXP) (CIK 0001430306) (TNXP) — Feb 15, 2012
Tonix Pharmaceuticals Holding Corp. (TNXP) (CIK 0001430306)
Date: Feb. 15, 2012 · CIK: 0001430306 · Accession: 0000000000-12-008410
AI Filing Summary & Sentiment
File numbers found in text: 333-150149
Referenced dates: January 10, 2012
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February 15, 2012
Via E-mail
Seth Lederman President, Chief Executive Officer and Chairman Tonix Pharmaceuticals Holding Corp. 509 Madison Avenue, Suite 306 New York, New York 10022
Re: Tonix Pharmaceuticals Holding Corp.
Current Report on Form 8-K
Response dated February 3, 2012 File No. 333-150149
Dear Mr. Lederman:
We have reviewed your response to our commen ts and have the following comments. In
some of our comments, we may ask you to provi de us with information so we may better
understand your disclosure.
Please respond to this letter within ten business days by amending your filing, by
providing the requested information, or by advi sing us when you will provide the requested
response. If you do not believe our comments apply to your fact s and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing an amendment to your fili ng and the information you provide in response
to these comments, we may have additional comments.
Business Overview, page 4
1. We note your response to prior comment 1 of our letter dated January 10, 2012. We also
note references on pages 15, 16, 29 and elsewh ere to the “general ly lengthy” and
“substantial time” associated with the FDA approval process, the FDA’s “established
performance goals for review of NDAs” and the statement that “[p]roduct sales in the
United States may commence only when an NDA is approved.” With a view to
clarifying disclosure, advise us in approximate quantified terms of the minimum amount
of time—for example, in quarters or y ears—you believe is required to bring your
principal products to market. It is unclea r if you plan, for example, to apply for and
receive FDA approval within 1 year, 2 years or a certain amount of time that is shorter or
longer than 1 or 2 years. We understand, as indicated in your response, that other
factors, including “financial” and “research results,” likely affect the time it takes to
Seth Lederman Tonix Pharmaceuticals Holding Corp. February 15, 2012 Page 2
reach commercialization. Please include with your estimate any material assumptions
underlying such factors as you deem necessary.
2. Please refer to prior comment 2. Given the apparently existing use by your competitors
of cyclobenzaprine as a treatment for fibr omyalgia syndrome, please clarify what new
uses you currently target. Also in this regar d, please refer to the 8- K disclosure that you
“pursue development and regulatory approval pathways by reformulating versions of
approved drugs for new uses and by using the Section 505(b)(2) pathway for FDA
approval.” It is unclear if th e reference in your response lette r to the “specific therapeutic
use targeted for the active ingredient that relates to cyclobenzapri ne” would be a “new
use.” If not, please revise the cited 8-K disclosure accordingly.
Intellectual Property, page 14
3. We note your response to comment 4 from our letter dated January 10, 2012. It is
unclear why you disclose that th e intellectual property was “gra nted.” Please revise or
advise.
Risk Factors, page 20
4. We note your response to prior comment 5 rega rding the assumption that there will be a
significant market-wide increase in the use of muscle relaxants for the treatment of FM.
Although your business plan may not be “who lly-dependent upon the assumption,” it is
unclear why you believe the substantially increas ed use is not a material assumption that
should be addressed in Risk Factors or Business. Please revise or advise.
We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing to be certain that the filing include s the information the Securities Exchange Act of
1934 and all applicable Exchange Act rules requir e. Since the company and its management are
in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made. In responding to our comments, please provi de a written statement from the company
acknowledging that:
the company is responsible for the adequacy an d accuracy of the disclo sure in the filing;
staff comments or changes to disclosure in response to staff comments do not foreclose
the Commission from taking any action with respect to the filing; and
the company may not assert staff comments as a defense in any proceeding initiated by
the Commission or any person under the federa l securities laws of the United States.
You may contact Joanna Lam, Staff Accountant, at (202) 551-3476 or John Archfield,
Senior Staff Accountant, at (202) 551-3315 if you have questi ons regarding comments on the
Seth Lederman Tonix Pharmaceuticals Holding Corp. February 15, 2012 Page 3
financial statements and related matters. Please contact Ruairi Regan, St aff Attorney, at (202)
551-3269 or James Lopez, Branch Chief, at (202) 551-3536 with any other questions.
S i n c e r e l y ,
/s/ James Lopez (for)
John Reynolds
Assistant Director
cc: (via e-mail) Harvey Kesner, Esq. Sichenzia Ross Friedman Ference Anslow LLP