|
|
|
|
Jonathan
Friedman
|
|
|
|
Direct
Voice
|
818.444.4514
|
|
Direct
Fax
|
818.444.6314
|
|
E-Mail
|
jfriedman@biztechlaw.com
|
March 15,
2010
VIA
EDGAR
Securities
and Exchange Commission
Mail Stop
3561
Washington,
D.C. 20549-3561
Form
10-K for Fiscal Year Ended September 30, 2009
Filed
December 30, 2009
File
No. 000-26285
Dear Mr.
Reynolds:
On behalf
of CNS Response, Inc. (the “Company”),
we hereby provide the following responses in reply to the Staff’s comment
letter, dated March 1, 2010 (the “Comment
Letter”). The factual information provided herein relating to
the Company has been provided to us by the Company. Paragraph
numbering used for the response set forth below corresponds to the numbering
used in the Comment Letter.
Form 10-K for Fiscal Year
Ended September 30, 2009
1. We
note from Exhibit 23.1 that your auditors consent to the incorporation by
reference of their report in the Form S-8 (File No. 333-150398). We also note
disclosure that appears to require consents pursuant to rule 436 and Section
7(a) of the Securities Act. For example, on page nine, you present
test results performed by the Center for Health Economics, Epidemiology and
Science Policy of United BioSource, which relate to your product. You
similarly quote statements from Milliman Global on page ten. Please
revise to provide these consents or provide us with your analysis as to why such
consents are not required. We may have further comment.
The
Company intends to file an amendment to its Form 10-K to delete the disclosure
relating to the test results performed by the Center for Health Economics,
Epidemiology and Science Policy of United BioSource on page
nine. Similarly, the Company intends to amend its Form 10-K to delete
the quoted statements from Milliman Global on page ten.
15260
Ventura Boulevard, 20th Floor,
Sherman Oaks, California 91403
office
>
818.444.4500 fax >
818.444.4520 www.biztechlaw.com
|
|
Securities
and Exchange Commission
March
15, 2010
Page
2
|
Part II
Item 5 Market for
Registration’s Common Equity, Related Stockholder Matters and Issuer Purchases
of Equity Securities, page 37
2. We
note that you have made unregistered sales of your securities as disclosed in
response to Item 5 of Form 10-K. You also disclose sales made on a
Form 8-K filed January 7, 2010. It was unclear why Form Ds were not
filed for these sales. Please advise or revise.
The
Company filed a Form D with the Securities and Exchange Commission on September
8, 2009. In that filing, the Company disclosed that it sold
$2,043,000 of “equity securities” and “options, warrants or other rights to
acquire another security” and intended to raise aggregate proceeds in the
offering of $6,426,000. The Company’s 8-K filed on January 7, 2010
disclosed additional closings to the offering covered by the Form D filed on
September 8, 2009. According to the SEC’s “Filing and Amending a Form
D Notice – A Compliance Guide for Small Entities and Others”, no amendment to a
Form D is required to amend the amount of securities sold in the offering or the
amount remaining to be sold. Therefore, the Company asserts that no
additional Form D filing is required in relation to its equity
financing.
Notwithstanding
the foregoing, on or about March 15, 2010, the Company will file with
the Securities and Exchange Commission a Form D to disclose its sale of Secured
Convertible Promissory Notes to two accredited investor on March 30, 2009, a
Form D to disclose its sale of a Secured Convertible Promissory Note and warrant
to one accredited investor on May 14, 2009, and a Form D to disclose its sale of
a Secured Convertible Promissory Note and warrant to one accredited investor on
June 12, 2009. Each of these debt financings are referred to in the
disclosure contained in Item 5 of the Company’s Form 10-K.
Item 7 Management’s
Discussion and Analysis of Financial Condition and Results of Operations, page
42
3. We
note your disclosure on page 16 of your Form 10-K that the FDA has contacted you
three times since 2008 objecting to your apparent failure to obtain FDA approval
or clearance for the sale of your rEEG product. It is unclear why you
do not believe the warning letters and communications from the FDA should not be
addressed as a material event or uncertainty that may have an impact on your
operations under Item 303 of Regulation S-K. Please refer to Release
No. 33-8350 (http://www.sec.gov/rules/interp/33-8350.htm). In
this regard, disclosure regarding your belief that your rEEG is “a service to
aid in medication selection and not a diagnosis aid” should clarify the basis
for this belief and include a brief explanation of the difference between the
two types of aid.
|
|
Securities
and Exchange Commission
March
15, 2010
Page
3
|
SEC Release Number 33-8350 provides
that a company must identify and disclose in its MD&A known trends, events,
demands, commitments and uncertainties that are reasonably likely to have a
material effect on financial condition or operating
performance. After internal discussion and consultation with the
Company’s advisors, the Company determined that the warning letter and
subsequent communications with the FDA were not required to be disclosed in the
Company’s MD&A for its fiscal year ended September 30, 2009.
The
Company reached this conclusion since, at the time the Company filed its Annual
Report on Form 10-K, the Company could not determine what impact, if any, the
communications from the FDA would have on its financial condition and results of
operations. Upon receipt of the most recent letter from the FDA, the
Company planned to request a meeting with the FDA to advocate its position and
discuss the scope and requirements for 510(k) clearance that they might require,
if any.
In
addition, at the time the Company filed its Annual Report on Form 10-K, the
Company concluded that its disclosure of its communications with the FDA was
sufficient. The Company’s correspondence with the FDA and the
possibility of future FDA regulation and its potential impact on the Company is
prominently disclosed in the Company’s Annual Report as part of the Company’s
discussion of its business under the heading “Government Regulation”, in the
“Risk Factors” section of the document as well as in Note 12 to the Company’s
Consolidated Financial Statements. The Company therefore concluded
that repeating this information in the MD&A section of its Annual Report,
since the impact it would have on its financial condition and results of
operations could not be determined, would be redundant and would not provide any
additional insight to investors than the disclosure already contained in the
document.
Although the Company believes that the
sale of its Laboratory Information Services, including its rEEG Reports, are not
subject to regulatory pre-market approval, the Company recently elected to seek
510(k) clearance with the FDA for various business reasons. The
Company is in the process of evaluating what impact its 510(k) application will
have on its financial condition and operating performance and will discuss its
510(k) application in its next Quarterly Report on Form 10-Q.
|
|
Securities
and Exchange Commission
March
15, 2010
Page
4
|
Item 9A(T) – Controls and
Procedures, page 80
4. We
note that your management has concluded that your disclosure controls and
procedures and internal control over financial reporting were not effective at
September 30, 2009. However, it does not appear that you have
provided management’s plans, or actions already taken, to remediate the material
weakness identified in your filing. Please revise to provide a
discussion of management’s remediation plans as it relates to both your
ineffective disclosure controls and procedures and internal control over
financial reporting.
In the
Company’s Quarterly Report on Form 10-Q for the period ended December 31, 2009
filed with the Securities and Exchange Commission on February 16, 2010, the
Company disclosed the same significant deficiencies as it disclosed in its
Annual Report on Form 10-K for the fiscal year ended September 30,
2009. In the Company’s Quarterly Report on Form 10-Q, the Company
also disclosed the following: “To address the identified significant
deficiencies, the Company plans to increase its segregation of duties,
particularly with respect to NTC, by having more accounting functions undertaken
by personnel at Company headquarters. The Company is also planning to
develop a comprehensive and formal accounting and procedures manual and intends
to hire a Chief Financial Officer.”
Subsequent
to the filing of its Quarterly Report on Form 10-Q, on February 18, 2010, the
Company appointed Paul Buck to the position of Chief Financial
Officer. As a result of Mr. Buck’s appointment, the Company cured a
significant deficiency reported in its Annual Report on Form 10-K and subsequent
Quarterly Report on Form 10-Q since the Company now has personnel with
sufficient financial expertise in the capacity of Chief Financial
Officer.
Moreover,
following his appointment, Mr. Buck has assumed some of the accounting functions
formerly undertaken by the Company’s NTC office in Denver,
Colorado. The assumption of these tasks by Mr. Buck and others at the
Company’s head office in Aliso Viejo, California have improved the Company’s
segregation of duties in the accounting and finance function. The
Company intends to further improve the segregation of duties within the
accounting and finance function by having key management personnel, with
budgetary responsibility, review and approve all expenditures before they are
entered into the Company’s accounting system and processed for
payment. As the Company increases in size, the Company will further
segregate duties in the accounting and finance function as opportunities
arise.
With
respect to the third significant deficiency identified by the Company in its
filings with the Securities and Exchange Commission (the Company’s failure to
have a comprehensive and formalized accounting and procedures manual), the
Company’s plans to mitigate this deficiency have not changed since the filing of
its Quarterly Report on Form 10-Q. The Company still plans to develop
such a manual by formally documenting key transactions cycles and undertaking
risk assessments in order to enhance its internal controls.
|
|
Securities
and Exchange Commission
March
15, 2010
Page
5
|
In its
Quarterly Report on Form 10-Q for the period ended March 31, 2010, the Company
will disclose the changes in its Disclosure Controls and Procedures and changes
in Internal Control Over Financial Reporting described above.
The
Company acknowledges that:
|
|
·
|
the
Company is responsible for the adequacy and accuracy of the disclosure 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 federal securities
laws of the United States.
|
We hope
the above has been responsive to the Staff’s comments. If you have
any questions or require any additional information or documents, please
telephone me at 818-444-4514.
| |
|
Sincerely,
|
|
| |
|
|
|
|
|
|
/s/
Jonathan Friedman
|
|
| |
|
|
|
| |
|
Jonathan
Friedman
|
|
Paul
Buck