SEC Company Response from CUMBERLAND PHARMACEUTICALS INC (CPIX) (CIK 0001087294) (CPIX) — Jun 22, 2007
CUMBERLAND PHARMACEUTICALS INC (CPIX) (CIK 0001087294)
Date: June 22, 2007 · CIK: 0001087294 · Accession: 0000950144-07-005951
AI Filing Summary & Sentiment
Reasoning
File numbers found in text: 333-142535
Referenced dates: June 8, 2007
Letter
Cumberland Pharmaceuticals Inc.
[A&R Letterhead]
June 22, 2007
United States Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Mr. Jeffrey P. Riedler
Assistant Director
Re:
Cumberland Pharmaceuticals Inc.
Form S-1 Registration Statement
File No. 333-142535
Ladies and Gentlemen:
We are responding to comments received in a letter dated June 8, 2007 from Mr. Jeffrey P. Riedler to Mr. A.J. Kazimi with respect to the Form S-1 Registration Statement of Cumberland Pharmaceuticals Inc. filed on May 1, 2007. For your convenience, we have repeated in bold type the comments and requests for additional information exactly as set forth in Mr. Riedler’s letter. On the date hereof, we have filed Amendment No. 1 to the Registration Statement reflecting all changes discussed herein.
The following paragraphs set forth the responses of Cumberland Pharmaceuticals Inc. to the comments contained in Mr. Riedler’s letter of June 8, 2007. All page references below are to page numbers in the Registration Statement, filed May 1, 2007, except as otherwise set forth herein. For your convenience, a marked copy of Amendment No. 1, comparing Amendment No. 1 to the Registration Statement, is enclosed herewith.
Comments Applicable to the Entire Document
1.
We note that your filing contains numerous omissions throughout the prospectus which relate to the offering price range or the number of shares you will sell. These omissions include but are not limited to:
•
Summary Financial Data
•
The Option Grants Table
•
Use of Proceeds
•
Shares Eligible for Future Sale
•
Capitalization
•
The Principal Stockholders Table
•
Dilution
•
Description of Capital Stock
Rule 430A requires you to include this information in your filing based upon an estimate of the offering price within a bona fide range you disclose on the cover page
Securities and Exchange Commission
June 22, 2007
Page 2
and based upon an estimate of the number of shares you will sell. We consider a bona fide range to be $2 if the price is under $20 and 10% if it is above $20. You should include the required information in an amendment prior to circulating a “red herring” prospectus.
Response:
The Company will comply with this comment by filing an amendment containing all of the information required by Rule 430A at the time that the “red herring” prospectus is filed, and prior to the road show.
2.
Provide us with copies of all the graphic, photographic or artistic materials you intend to include in the prospectus prior to its printing and use. Please note that we may have comments. Please also note that all textual information in the graphic material should be brief and comply with the plain English guidelines regarding jargon and technical language.
Response:
By separate cover, the Company is providing the Commission Staff copies of the graphic materials that the Company proposes to include in the prospectus.
3.
Comments on your application for confidential treatment will follow under separate cover. We will not consider a request for acceleration of effectiveness of the registration statement until any comments we may have on the application are resolved.
Response:
We will await receipt of your comments regarding the Company’s request for confidential treatment of certain proprietary information.
4.
Please update your interim financial statements and related financial information as required by Rule 3-12 of Regulation S-X.
Response:
The Company has complied with this comment by updating the interim financial statements and related financial information in Amendment No. 1 to include financial statements as of March 31, 2007 and covering the three months ended March 31, 2006 and March 31, 2007.
Securities and Exchange Commission
June 22, 2007
Page 3
Prospectus Summary
5.
Please disclose your accumulated deficit.
Response:
The Company has complied with this comment by inserting in the tables on pages 5 and 27 of the Registration Statement (pages 5 and 30 of Amendment No. 1) an accumulated deficit line item as of March 31, 2007 of $6,620,820.
6.
Please revise your statement that you expect Amelior to be the first injectable product approved for pain and fever. You should not assume you will receive FDA approval. Similarly, revise page 45.
Response:
The Company has complied with this comment by deleting the fourth full paragraph on page 1 and substituting, in lieu thereof, a revised paragraph (page 1 of Amendment No. 1). Corresponding changes have been made on page 39 (page 47 of Amendment No. 1) and page 45 (page 53 of Amendment No. 1).
7.
Please delete the statement that you believe Amelior is a safe and effective treatment. Safety and efficacy is still being tested and are determinations made by the FDA.
Response:
The Company has complied with this comment by deleting the sentence as requested.
8.
Please provide third party support for your statement that NAC is accepted as the worldwide standard of care for treating acetaminophen overdose.
Response:
In making this assertion, the Company is relying in part on an article, entitled “An update of N- acetylcysteine treatment for acute acetaminophen toxicity in children” by Laurie Marzullo, published by Lippincott Williams & Wilkins, Curr Opin Pediatr 17:239-245, 2005. On page 240, Ms. Marzullo states that “The accepted antidote for ingestion of toxic levels of acetaminophen is N- acetylcysteine (NAC), as published by Prescott et al.”
The Company is furnishing to the Commission Staff a copy of the article by separate cover. Other articles support the Company’s position that NAC is the protocol for treatment of acetaminophen overdose. If the Commission Staff would like supplemental support for this position, we would be happy to supply additional support at its request.
Securities and Exchange Commission
June 22, 2007
Page 4
9.
Please provide your basis for your belief that you can continue to expand your market share of Acetadote. Since Acetadote is the only intravenous formulation of N-acetylcysteine, how are your defining the market?
Response:
The Company defines the market for Acetadote to include users of both the intravenous formulation and the oral formulation of N-acetylcysteine, or NAC. According to a survey by the American Association of Poison Control Centers’ Toxic Exposure Surveillance System, approximately 66% of people treated with NAC in 2005 were given an oral formulation. This survey is not comprehensive of total NAC use in the U.S. and the Company believes that oral NAC was used in an even greater percent of cases nationwide during that year based on an internal analysis of oral NAC sales from data provided by Wolters Kluwer. The Company believes that intravenously administered Acetadote has clinical and financial benefits relative to orally administered NAC, including ease of administration, minimizing nausea and vomiting associated with oral NAC, accurate dosage control, shorter treatment protocol and reduction in overall cost of acetaminophen overdose management, as discussed on page 47 of the Registration Statement (page 55 of Amendment No. 1). The Company believes that Acetadote also offers significant cost advantages to both patients and hospitals by reducing the treatment regimen, usually from three days to one day. For these reasons, the Company feels that the use of Acetadote will continue to grow as patients and hospitals increasingly favor Acetadote over orally administered NAC.
10.
We note your discussion related to early-stage product candidates, please clarify what you meant by “early-stage.” For example, do you mean are these products in pre-clinical trials, Phase I trials, or have they not yet reached the pre-clinical trial stage?
Response:
The Company has complied with this comment by amending the first sentence of the fourth full paragraph on page 2 (page 2 of Amendment No. 1). Additionally, the Company has complied with this comment by amending similar language on page 40 (page 48 of Amendment No. 1).
Summary Consolidated Financial Data — page 5
11.
Please provide pro forma net income per share amounts for the most recent fiscal year and interim period to give effect to the conversion of preferred stock into common stock. Please refer to Rule 11-01(a) of Regulation S-X.
Response:
Securities and Exchange Commission
June 22, 2007
Page 5
The Company has complied with this comment by including pro forma net income per share information in the table on page 5 (page 5 of Amendment No. 1).
Risk Factors — page 6
12.
Please revise the introductory paragraph to eliminate the reference to other unforeseen risks. You should not caution against risks that are not identified and described.
Response:
The Company has complied with this comment by amending the introductory paragraph on page 6 (page 6 of Amendment No. 1) to delete the third sentence.
We currently market two products, Acedote and Kristalose. An adverse development regarding either of these products could have a material and adverse impact on us. — page 7
13.
This discussion is too broad. Please revise this risk factor to more specifically identify the types of changes that could have and adverse impact and the likely impact.
Response:
The Company has complied with this comment by deleting the existing risk factor and replacing it with a revised risk factor on page 7 (page 7 of Amendment No. 1).
14.
If there have been any reports of adverse effects from these products, please specifically identify them.
Response:
The Company has complied with this comment by inserting a new paragraph at the end of the risk factor described in Comment No. 13.
If any manufacturer we rely on fails to produce our products and product candidates in the amounts we require on a timely basis, or fails to comply with stringent regulations applicable to pharmaceutical drug manufacturers, we may face delays in the commercialization of Amelior, or may be unable to meet demand for the product supplied by the manufacturer and may lose potential revenues. — page 7
15.
Does your agreement with Bioniche allow you to obtain Acetadote from another source if they are unable to supply sufficient quantities of Acetadote? If it does not,
Securities and Exchange Commission
June 22, 2007
Page 6
please revise the discussion to specifically state this information. Similarly, state whether you can obtain Kristalose from any party other than Inalco.
Response:
The Company’s agreement with Bioniche allows the Company to obtain Acetadote from another source if Bioniche is unable to supply sufficient quantities of Acetadote. The Company’s agreement with Inalco does not expressly authorize the Company to obtain Kristalose from a party other than Inalco if Inalco is unable to supply sufficient quantities of Kristalose. Accordingly, the Company has complied with this comment by revising the language in the risk factor on page 7 (page 8 of Amendment No. 1).
Competitive pressures could reduce our revenues and profits. — page 9
16.
Please revise the risk factor to identify the two competing laxative products and their manufacturers as well as the identity of the company developing the intravenous acetaminophen product.
Response:
The Company has complied with this comment by revising the second paragraph of this risk factor as set forth on page 9 (page 9 of Amendment No. 1).
Our future growth depends on our ability to identify and acquire rights to products. If we do not successfully identify and acquire rights to products and successfully integrate them into our operations, our growth opportunities would be limited. — page 9
17.
In the last paragraph of this risk factor you indicate that you are not precluded from engaging in a large acquisition in the future, including an acquisition that entails the investment of substantially all of the proceeds from this offering. Please disclose whether you are currently contemplating, discussing or negotiating an acquisition. If so, you should provide appropriate disclosure in the relevant places in the prospectus, including the “Use of Proceeds” section. If you do not have such plans, please state that you have no current acquisition plans.
Response:
The Company advises the Commission Staff that while we continually screen and evaluate potential acquisitions of product candidates, intellectual property rights or companies that complement our business, we have no current commitments or agreements for such acquisitions. The Company has stated this on page 10 of Amendment No. 1.
The size of our organization and our activities are growing, and we may experience difficulties in managing growth. — page 11
Securities and Exchange Commission
June 22, 2007
Page 7
18.
It is unclear whether the number of employees disclosed includes the sales staff you recently acquired from Cardinal. Please clarify the disclosure.
Response:
The Company has complied with this comment by amending the first sentence of this risk factor as set forth on page 11 (page 12 of Amendment No. 1).
Our strategy to secure and extend marketing exclusivity or patent rights may provide only limited protection from competition. — page 14
19. Please explain what the terms “priority filing date” and “orphan drug” mean.
Response:
The Company has complied with this comment by eliminating the reference to the technical term “priority filing date” and has amended the third sentence of the last paragraph on page 14 (page 15 of Amendment No. 1) and has added an additional explanatory paragraph regarding orphan drug designation.
We refer the Commission Staff to the Orphan Drug Designation paragraph under the “Business” section on page 57 (page 66 of Amendment No. 1) for a full explanation of orphan drug designation.
20. Please tell us you basis for market exclusivity for Amelior.
Response:
The Company is basing its claim for market exclusivity for Amelior upon the Hatch-Waxman Act, which provides three years of marketing exclusivity for the approval of new and supplemental NDAs, including Section 505(b)(2) NDAs, for, among other things, new indications, dosages or strengths of an existing drug, if new clinical investigations that were conducted or sponsored by the applicant are essential to the approval of the application. The Company explains this legal provision in paragraph 1 on page 58 (page 66 of Amendment No. 1) entitled The Hatch-Waxman Act under the Business section of the Registration Statement.
Use of Proceeds — page 23
21.
Please expand the disclosure in this section to identify the amount of proceeds you intend to spend on each identified purpose. Also, please be more specific about what the purposes are.
Response:
Securities and Exchange Commission
June 22, 2007
Page 8
The Company has complied with this comment by deleting the second paragraph of the Use of proceeds section on page 23 and replacing it with several additional paragraphs (page 24 of Amendment No. 1).
22.
You say that you may use a portion of the proceeds for product development and expansion. Please identify the products you intend to develop with proceeds from this offering. Disclose the amount of proceeds you intend to spend on development of each product and discuss how far along in the development process the proceeds will take you. Disclose the amount of additional funds you anticipate will be necessary to complete development and market the product. If additional funds will be required disclose the source you anticipate obtaining the funds from, as w
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filename1.htm
Cumberland Pharmaceuticals Inc.
[A&R Letterhead]
June 22, 2007
United States Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Mr. Jeffrey P. Riedler
Assistant Director
Re:
Cumberland Pharmaceuticals Inc.
Form S-1 Registration Statement
File No. 333-142535
Ladies and Gentlemen:
We are responding to comments received in a letter dated June 8, 2007 from Mr. Jeffrey P.
Riedler to Mr. A.J. Kazimi with respect to the Form S-1 Registration Statement of Cumberland
Pharmaceuticals Inc. filed on May 1, 2007. For your convenience, we have repeated in bold type the
comments and requests for additional information exactly as set forth in Mr. Riedler’s letter. On
the date hereof, we have filed Amendment No. 1 to the Registration Statement reflecting all changes
discussed herein.
The following paragraphs set forth the responses of Cumberland Pharmaceuticals Inc. to the
comments contained in Mr. Riedler’s letter of June 8, 2007. All page references below are to page
numbers in the Registration Statement, filed May 1, 2007, except as otherwise set forth herein. For
your convenience, a marked copy of Amendment No. 1, comparing Amendment No. 1 to the Registration
Statement, is enclosed herewith.
Comments Applicable to the Entire Document
1.
We note that your filing contains numerous omissions throughout the prospectus which relate
to the offering price range or the number of shares you will sell. These omissions include
but are not limited to:
•
Summary Financial Data
•
The Option Grants Table
•
Use of Proceeds
•
Shares Eligible for Future Sale
•
Capitalization
•
The Principal Stockholders Table
•
Dilution
•
Description of Capital Stock
Rule 430A requires you to include this information in your filing based upon an estimate of
the offering price within a bona fide range you disclose on the cover page
Securities and Exchange Commission
June 22, 2007
Page 2
and based upon an estimate of the number of shares you will sell. We consider a bona fide
range to be $2 if the price is under $20 and 10% if it is above $20.
You should
include the required information in an amendment prior to circulating a “red herring”
prospectus.
Response:
The Company will comply with this comment by filing an amendment containing all of the
information required by Rule 430A at the time that the “red herring” prospectus is filed, and prior
to the road show.
2.
Provide us with copies of all the graphic, photographic or artistic materials you intend to
include in the prospectus prior to its printing and use. Please note that we may have
comments. Please also note that all textual information in the graphic material should be
brief and comply with the plain English guidelines regarding jargon and technical language.
Response:
By separate cover, the Company is providing the Commission Staff copies of the graphic
materials that the Company proposes to include in the prospectus.
3.
Comments on your application for confidential treatment will follow under separate cover. We
will not consider a request for acceleration of effectiveness of the registration statement
until any comments we may have on the application are resolved.
Response:
We will await receipt of your comments regarding the Company’s request for confidential
treatment of certain proprietary information.
4.
Please update your interim financial statements and related financial information as required
by Rule 3-12 of Regulation S-X.
Response:
The Company has complied with this comment by updating the interim financial statements and
related financial information in Amendment No. 1 to include financial statements as of March 31,
2007 and covering the three months ended March 31, 2006 and March 31, 2007.
Securities and Exchange Commission
June 22, 2007
Page 3
Prospectus Summary
5.
Please disclose your accumulated deficit.
Response:
The Company has complied with this comment by inserting in the tables on pages 5 and 27 of the
Registration Statement (pages 5 and 30 of Amendment No. 1) an accumulated deficit line item as of March 31, 2007 of $6,620,820.
6.
Please revise your statement that you expect Amelior to be the first injectable product
approved for pain and fever. You should not assume you will receive FDA approval. Similarly,
revise page 45.
Response:
The Company has complied with this comment by deleting the fourth full paragraph on page 1 and
substituting, in lieu thereof, a revised paragraph (page 1 of Amendment No. 1). Corresponding
changes have been made on page 39 (page 47 of Amendment
No. 1) and page 45 (page 53 of Amendment No. 1).
7.
Please delete the statement that you believe Amelior is a safe and effective treatment.
Safety and efficacy is still being tested and are determinations made by the FDA.
Response:
The Company has complied with this comment by deleting the sentence as requested.
8.
Please provide third party support for your statement that NAC is accepted as the worldwide
standard of care for treating acetaminophen overdose.
Response:
In making this assertion, the Company is relying in part on an article, entitled “An update of
N- acetylcysteine treatment for acute acetaminophen toxicity in children” by Laurie Marzullo,
published by Lippincott Williams & Wilkins, Curr Opin Pediatr 17:239-245, 2005. On page 240, Ms.
Marzullo states that “The accepted antidote for ingestion of toxic levels of acetaminophen is N-
acetylcysteine (NAC), as published by Prescott et al.”
The
Company is furnishing to the Commission Staff a copy of the article
by separate cover. Other articles support the Company’s position that NAC is the protocol for
treatment of acetaminophen overdose. If the Commission Staff would like supplemental support for
this position, we would be happy to supply additional support at its request.
Securities and Exchange Commission
June 22, 2007
Page 4
9.
Please provide your basis for your belief that you can continue to expand your market share
of Acetadote. Since Acetadote is the only intravenous formulation of N-acetylcysteine, how
are your defining the market?
Response:
The Company defines the market for Acetadote to include users of both the intravenous
formulation and the oral formulation of N-acetylcysteine, or NAC. According to a survey by the
American Association of Poison Control Centers’ Toxic Exposure Surveillance System, approximately
66% of people treated with NAC in 2005 were given an oral formulation. This survey is not
comprehensive of total NAC use in the U.S. and the Company believes that oral NAC was used in an
even greater percent of cases nationwide during that year based on an internal analysis of oral NAC
sales from data provided by Wolters Kluwer. The Company believes that intravenously administered
Acetadote has clinical and financial benefits relative to orally administered NAC, including ease
of administration, minimizing nausea and vomiting associated with oral NAC, accurate dosage
control, shorter treatment protocol and reduction in overall cost of acetaminophen overdose
management, as discussed on page 47 of the Registration Statement
(page 55 of Amendment No. 1). The Company believes that Acetadote also offers significant
cost advantages to both patients and hospitals by reducing the treatment regimen, usually from
three days to one day. For these reasons, the Company feels that the use of Acetadote will
continue to grow as patients and hospitals increasingly favor Acetadote over orally administered
NAC.
10.
We note your discussion related to early-stage product candidates, please clarify what you
meant by “early-stage.” For example, do you mean are these products in pre-clinical trials,
Phase I trials, or have they not yet reached the pre-clinical trial stage?
Response:
The Company has complied with this comment by amending the first sentence of the fourth full
paragraph on page 2 (page 2 of Amendment No. 1). Additionally, the Company has complied with
this comment by amending similar language on page 40 (page 48 of Amendment No. 1).
Summary Consolidated Financial Data — page 5
11.
Please provide pro forma net income per share amounts for the most recent fiscal year and
interim period to give effect to the conversion of preferred stock into common stock. Please
refer to Rule 11-01(a) of Regulation S-X.
Response:
Securities and Exchange Commission
June 22, 2007
Page 5
The Company has complied with this comment by including pro forma net income per share
information in the table on page 5 (page 5 of Amendment No. 1).
Risk Factors — page 6
12.
Please revise the introductory paragraph to eliminate the reference to other unforeseen
risks. You should not caution against risks that are not identified and described.
Response:
The Company has complied with this comment by amending the introductory paragraph on page 6
(page 6 of Amendment No. 1) to delete the third sentence.
We currently market two products, Acedote and Kristalose. An adverse development regarding
either of these products could have a material and adverse impact on us. — page 7
13.
This discussion is too broad. Please revise this risk factor to more specifically identify
the types of changes that could have and adverse impact and the likely impact.
Response:
The Company has complied with this comment by deleting the existing risk factor and replacing
it with a revised risk factor on page 7 (page 7 of Amendment No. 1).
14.
If there have been any reports of adverse effects from these products, please specifically
identify them.
Response:
The
Company has complied with this comment by inserting a new
paragraph at the end of the risk
factor described in Comment No. 13.
If any manufacturer we rely on fails to produce our products and product candidates in the
amounts we require on a timely basis, or fails to comply with stringent regulations applicable to
pharmaceutical drug manufacturers, we may face delays in the commercialization of Amelior, or may
be unable to meet demand for the product supplied by the manufacturer and may lose potential
revenues. — page 7
15.
Does your agreement with Bioniche allow you to obtain Acetadote from another source if they
are unable to supply sufficient quantities of Acetadote? If it does not,
Securities and Exchange Commission
June 22, 2007
Page 6
please revise the discussion to specifically state this information. Similarly, state
whether you can obtain Kristalose from any party other than Inalco.
Response:
The Company’s agreement with Bioniche allows the Company to obtain Acetadote from another
source if Bioniche is unable to supply sufficient quantities of Acetadote. The Company’s agreement
with Inalco does not expressly authorize the Company to obtain Kristalose from a party other than
Inalco if Inalco is unable to supply sufficient quantities of Kristalose. Accordingly, the Company
has complied with this comment by revising the language in the risk
factor on page 7 (page 8 of
Amendment No. 1).
Competitive pressures could reduce our revenues and profits. — page 9
16.
Please revise the risk factor to identify the two competing laxative products and their
manufacturers as well as the identity of the company developing the intravenous acetaminophen
product.
Response:
The Company has complied with this comment by revising the second paragraph of this risk
factor as set forth on page 9 (page 9 of Amendment No. 1).
Our future growth depends on our ability to identify and acquire rights to products. If we do
not successfully identify and acquire rights to products and successfully integrate them into our
operations, our growth opportunities would be limited. — page 9
17.
In the last paragraph of this risk factor you indicate that you are not precluded from
engaging in a large acquisition in the future, including an acquisition that entails the
investment of substantially all of the proceeds from this offering. Please disclose whether
you are currently contemplating, discussing or negotiating an acquisition. If so, you should
provide appropriate disclosure in the relevant places in the prospectus, including the “Use of
Proceeds” section. If you do not have such plans, please state that you have no current
acquisition plans.
Response:
The Company advises the Commission Staff that while we continually screen and evaluate
potential acquisitions of product candidates, intellectual property
rights or companies that complement our business, we have no current
commitments or agreements for such acquisitions. The Company has
stated this on page 10 of Amendment No. 1.
The size of our organization and our activities are growing, and we may experience difficulties
in managing growth. — page 11
Securities and Exchange Commission
June 22, 2007
Page 7
18.
It is unclear whether the number of employees disclosed includes the sales staff you recently
acquired from Cardinal. Please clarify the disclosure.
Response:
The Company has complied with this comment by amending the first sentence of this risk factor
as set forth on page 11 (page 12 of Amendment No. 1).
Our strategy to secure and extend marketing exclusivity or patent rights may provide only
limited protection from competition. — page 14
19. Please explain what the terms “priority filing date” and “orphan drug” mean.
Response:
The Company has complied with this comment by eliminating the reference to the technical term
“priority filing date” and has amended the third sentence
of the last paragraph on page 14 (page 15 of Amendment No. 1) and has added an additional explanatory paragraph regarding orphan drug
designation.
We refer the Commission Staff to the Orphan Drug Designation paragraph under the “Business”
section on page 57 (page 66 of Amendment No. 1) for a full explanation of orphan drug designation.
20. Please tell us you basis for market exclusivity for Amelior.
Response:
The Company is basing its claim for market exclusivity for Amelior upon the Hatch-Waxman Act,
which provides three years of marketing exclusivity for the approval of new and supplemental NDAs,
including Section 505(b)(2) NDAs, for, among other things, new indications, dosages or strengths of
an existing drug, if new clinical investigations that were conducted or sponsored by the applicant
are essential to the approval of the application. The Company explains this legal provision in
paragraph 1 on page 58 (page 66 of Amendment No. 1) entitled The Hatch-Waxman Act under the Business section of the Registration
Statement.
Use of Proceeds — page 23
21.
Please expand the disclosure in this section to identify the amount of proceeds you intend to
spend on each identified purpose. Also, please be more specific about what the purposes are.
Response:
Securities and Exchange Commission
June 22, 2007
Page 8
The Company has complied with this comment by deleting the second paragraph of the Use of
proceeds section on page 23 and replacing it with several
additional paragraphs (page 24 of
Amendment No. 1).
22.
You say that you may use a portion of the proceeds for product development and expansion.
Please identify the products you intend to develop with proceeds from this offering. Disclose
the amount of proceeds you intend to spend on development of each product and discuss how far
along in the development process the proceeds will take you. Disclose the amount of
additional funds you anticipate will be necessary to complete development and market the
product. If additional funds will be required disclose the source you anticipate obtaining
the funds from, as w