April 1,
2010
VIA
EDGAR
Securities
and Exchange Commission
Mail Stop
3561
Washington,
D.C. 20549-3561
Form
10-K
Filed
December 30, 2009
File
No. 000-26285
Supplemental
Response Letter
Dated
March 16, 2010
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 22, 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.
General
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1.
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We
note your response to prior comment three from our letter dated March 1,
2010, and the statement that you could not determine what impact, if any,
the communications from the FDA would have on your financial condition and
results of operations. Please advise us of any analysis you
conducted consistent with the first two paragraphs and bullet points of
Section III.B.3 of Release No. 33-8350. With respect to future
disclosure addressing your recent decision to seek 510(k) clearance,
please advise us of the nature and location of such anticipated
disclosure.
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The
Company conducted an analysis consistent with the first two paragraphs and
bullet points of Section III.B.3 of Release No. 33-8350 in connection with the
correspondence received from the FDA and the preparation of its Annual Report on
Form 10-K. As discussed in the Annual Report, the Company disagrees
with the FDA regarding the regulatory status of its rEEG
service. After careful analysis, the Company's position is that it
provides medical database services, and does not manufacture or distribute
medical devices. The Company is confident that it is correct, and the
FDA is in error over whether rEEG is a device, and over whether the FDA has
jurisdiction over CNS Response and its rEEG service.
15260
Ventura Boulevard, 20th Floor,
Sherman Oaks, California 91403
office
>
818.444.4500 fax >
818.444.4520 www.biztechlaw.com
Securities
and Exchange Commission
April 1,
2010
Page
2
The
Company also believes that there is little risk of significant adverse
regulatory action from the FDA with respect to its rEEG service. The FDA warning
letters do not represent final action on the part of the
Agency. Instead, they are the FDA's current opinion on products that
it believes to be in violation of the Food Drug and Cosmetic Act. The
warning letters have no actual regulatory enforcement effect other than to
provide notice to the recipient that certain FDA officials believe that the
recipient is in violation. Further regulatory action would require
the FDA to initiate action for fines and/or injunction in Federal
Court. Since the Company doesn't actually sell any medical devices,
but rather offers its rEEG service to requesting physicians, there are no actual
products for the FDA to take action against through import detention, recall, or
seizure. The FDA would instead need to expend significant resources
to initiate court proceedings directly against the Company, and this is
something the FDA does not generally undertake unless there is a serious public
health risk. The FDA has also been reluctant to take court action in
situations where the legal basis for the action is suspect (as is the case with
rEEG). The fact that the FDA has not taken any action other than
through warning letters and other correspondence for over two years supports the
position that the Agency does not intend to take more serious and expensive
legal action. For this reason, the Company concluded at the time it
prepared its Annual Report on Form 10-K that it is not reasonably likely that
the communications received from the FDA will result in a material effect on the
company’s liquidity, capital resources or results of operations.
Going
forward, the Company intends to disclose its decision to seek 510(k) clearance
with the FDA in its current reports. The disclosure will appear in
the Company’s business discussion, in the risk factors section, as well as in
the MD & A under the applicable line item and in the footnotes to the
financial statements. The Company estimates that its 510(k)
application will cost $125,000 to prepare and file. At this time, the
Company does not anticipate that its decision to seek 510(k) clearance will have
a material effect the company’s liquidity, capital resources and results of
operations.
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.
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Sincerely,
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/s/
Jonathan Friedman
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Jonathan
Friedman
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