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SEC Comment Letter for MED GEN INC (CIK 0001045707) — Feb 23, 2005

MED GEN INC (CIK 0001045707)
Date: Feb. 23, 2005 · CIK: 0001045707 · Accession: 0000000000-05-008600

AI Filing Summary & Sentiment

File numbers found in text: 333-122093

Date
February 16, 2005
Author
Not clearly detected
Form
UPLOAD
Company
MED GEN INC (CIK 0001045707)

Letter

February 16, 2005 Mr. Paul Mitchell, President Med Gen, Inc. 7284 W. Palmetto Park Road - Suite 207 Boca Raton, Florida 33433 Form 10-KSB for the fiscal year ended September 30, 2004 Form 10-QSB for the period ended December 31, 2004 File No. 0-29171

Re: Med Gen, Inc. Form SB-2 Registration Statement File No. 333-122093

Dear Mr. Mitchell:

We have reviewed your filing and have the following comments. Where indicated, we think you should revise your document in response to these comments. If you disagree, we will consider your explanation as to why our comment is inapplicable or a revision is unnecessary. Please be as detailed as necessary in your explanation. In some of our comments, we may ask you to provide us with supplemental information so we may better understand your disclosure. After reviewing this information, we may or may not raise additional comments.

Please understand that the purpose of our review process is to assist you in your compliance with the applicable disclosure requirements and to enhance the overall disclosure in your filing. We look forward to working with you in these respects. We welcome any questions you may have about our comments or on any other aspect of our review. Feel free to call us at the telephone numbers listed at the end of this letter.

Comments applicable to the entire filing

1. Throughout the document you have improperly capitalized many words and terms that you are using for their common meanings. They include the following: "Company," "Prospectus," "Investors," "Offering," "Common Stock," "Pink Sheets," and "Annual Report." Please revise your document to limit use of capitalization to proper names and the first letters of sentences.

2. Throughout your document, you have made excessive use of the phrase "our Company," a term that is too vague and generic to be meaningful. Instead, please replace this term with words such as Med Gen, we, our, us or similar language that is more precise and descriptive.

Prospectus Cover Page

3. Information presented on the cover page should be limited to the information specified in Item 501(a) of Regulation S-B. Accordingly, please delete all but the portion of the first sentence of the first paragraph up to the comma, the second paragraph, all but the first sentence of the third paragraph and the fourth paragraph. You should also expand the disclosure regarding your stock price to include the asked price and to indicate that the prices may not reflect any actual transactions.

4. Please revise the cross reference to the risk factor section so that it is in bold face type.

Prospectus Summary

5. Please delete the last sentence of the introductory paragraph. This information is clear, or should be clear from the context.

6. Although you refer to this section as a "summary" of information contained elsewhere in the document, as currently written, it does not summarize any information at all. Instead, it simply repeats information you already provided on the cover page. If you choose to include a summary in your filing, the information in it should include a brief overview of your business and the offering. Please revise it accordingly.

Risk Factors - page 2

7. In this section and elsewhere in the registration statement you state that you "cannot assure you that," "there can be no assurance that," "there is no assurance that," and "cannot predict whether" various things will or will not happen. Statements such as these are legalistic and redundant. Please delete them. Instead, please be certain that you have adequately explained why you cannot make the assurance or prediction.

8. Additionally, describe the consequences if the event(s) that you cannot assure or predict will occur do not occur. For example:

* On page 2, you state that you cannot assure investors that any institution will be acting as a market maker for your stock at any time. Please revise to discuss the consequences if there are not market makers.

* On page 4, you state that you can`t assure investors that they will ever receive any cash, stock or other dividends on their shares. Please revise to discuss the consequences.

9. Many of your risk factor subheadings are simple statements of fact that do not identify a specific risk and its potential adverse consequences to an investor or the company. You will need to revise them so that they do. In addition, the subheading should accurately summarize the content of the body of the risk factor. The subheading should not be repeated in the body of the risk factor. Here are some examples of subheadings that need to be revised:

* "Our Company does not plan to issue dividends to its stockholders for the foreseeable future." - page 4

* "Our Company faces competition, and many of its competitors are larger and have more resources than our Company." - page 4

* "Our Company`s success is dependent upon its ability to manage anticipated growth." - page 5

* "Our Company depends on the performance of a network of distributors and brokers." - page 6

There is a limited trading market for our Company`s stock, which may cause our Company`s reported stock prices to be volatile and limit your ability to sell your shares. - page 2

10. It appears that you have combined two separate risks in this risk factor. One relates to your trading on the OTC Bulletin Board and the other relates to the market for stocks of OTC "wellness" companies. Please separate the risks so that each one is presented under an appropriate subheading.

11. Please delete the first sentence of the risk factor as it simply repeats information you already provided on the cover page. The second sentence is a mitigating statement that is inappropriate in a risk factor, and should also be deleted.

In the event that the price of our Company`s stock is less than $5.00 per share, as it currently is, our stock will be subject to the requirements for penny stocks, which could adversely affect your ability to sell and the market price of your shares. - page 3

12. As there is no indication that your stock price has ever been over $5.00, nor any indication that it is likely to be so in the foreseeable future, we think this subheading is inappropriately mitigating as it is currently written. We think it would be more appropriate to state that the stock is a "penny stock" under the federal securities laws, and as such, is subject to special trading rules that are likely to make it difficult to sell your shares at a price higher than an investor paid for them.

13. In the last sentence of the risk factor you refer to restrictions on the resale of the shares being registered. We do not understand what you are trying to say. Registered shares are supposed to be freely tradeable. Are you saying that the shares are subject to some additional restrictions? If so, you will need to disclose them.

In the future, our revenues and quarterly operating results may fluctuate, which may adversely affect the market price of our Company`s stock and could lead to our Company becoming the target of costly securities class action litigation. - page 3

14. Please delete the phrase "in the future" from the subheading. It suggests that you have not had such fluctuations in the past.

15. In the body of the risk factor you refer to the "expectations of market analysts." Are your shares currently being followed by market analysts? If so, please provide us with copies of these current analyses. If not, please delete the references to analysts.

16. As currently written, this risk factor could be discussing any company in your industry. Please revise it to more specifically describe your own situation. For example, we note the large drop in your revenue during the past year. How did this drop impact your stock price? Did you add any new products to your line? If so, how did that affect your stock price. The disclosure should also be quantified to the extent practicable.

You may suffer dilution of your investment if our Company issues additional securities; our Company has in the past and may in the future issue securities to its executive officers and directors. - page 4

17. Currently, both the subheading and the body of the risk factor are statements of fact that do not identify a specific risk and its potential adverse consequences. Please revise the risk factor accordingly. Also, you need to include a factual context for analyzing the risk. How many securities have you issued in each of the last two years and interim period? Who did you issue them to? What percentage of your outstanding shares do these issuances represent? How did these issuances affect the market for your shares?

Our Company does not plan to issue dividends to its stockholders for the foreseeable future. - page 4

18. The subheading and the body of this risk factor are also statements of fact that do not describe a specific risk and its likely adverse consequences. Please revise it accordingly. In light of your going concern opinion, we are not sure why a person making an investment in your company at the present time would consider the non-issuance of dividends to be a significant risk. Please explain in your revised disclosure.

Our company`s articles of incorporation and bylaws contain provisions that could delay or prevent a change in control. These provisions could limit the price that investors might be willing to pay in the future for shares of the Company`s common stock. - page 4

19. Please revise and expand the risk factor to be more specific. For example, is it an article of incorporation, a bylaw or a statute that permits you to issue preferred stock as stated in the first bullet. What is the supermajority voting requirement? What is the percentage of stock controlled by management? Does the supermajority requirement enable management to veto transactions that may be desired by other non-affiliated shareholders?

20. It appears that these provisions also serve to entrench current management of the company. Please include appropriate risk factor disclosure regarding this.

Through this Offering, our Company is registering a significant number of shares of common stock so that they are freely tradable, which may have a depressing effect on the market price of the common stock of our Company. - page 4

21. Currently, this risk factor makes a statement, but does not describe a specific risk and its potential adverse consequence for a person investing in this offering. Moreover, the body of the risk factor simply repeats the statement in the subheading. Please revise the risk factor and its subheading to describe a specific risk and its potential adverse consequences. Also, provide an adequate factual context, quantified to the extent practicable, for analyzing the risk.

Our Company faces competition, and many of its competitors are larger and have more resources than our Company. - page 4

22. Please revise the risk factor and its subheading to describe a specific risk and its potential adverse consequences for an investor in this offering. Include an adequate factual context as well. For example, who are your primary competitors? How does your market share compare to theirs? On what basis do you compete with them? How has your lack of financial resources affected your ability to compete? Has your consent decree with the FTC affected how you compete? How much do you anticipate it will cost you to effectively compete?

23. In the risk factor you state that you have "entered the magnet therapy market." We are unable to locate a discussion of this in the business section or MD&A. Please provide the appropriate disclosures regarding this activity, including an explanation of what it is, how much funding you will need to do this, and how you propose to obtain the funding.

Our Company`s success is dependent upon its ability to manage anticipated growth. - page 5

24. You state in the risk factor that your company intends to pursue "rapid growth." Please explain, in light of your current financial condition, how you propose to do this. Quantify the disclosure to the extent practicable. Your revised disclosure should also be specific about what the term "rapid growth" means for your business.

25. As currently written, the risk factor is so vague and abstract that it could apply to any company. Please revise it to be specific to your own situation.

In fiscal year 2004, our Company`s three largest customers were Wal- Mart, Walgreens and Eckerd which represented 66% of our Company`s annual sales that year... - page 5

26. Please revise the subheading and body to describe a specific risk and its potential adverse consequence. Also, delete the first sentence of the body of the risk factor since it simply repeats the subheading.

27. Disclose when you introduced the new brand and the percentage of revenue attributable to it.

28. Explain what you mean when you refer to "the issue of dominance" and how introducing a new product addresses it.

29. Do you have any reason to believe that you will lose any of your material customers? If so, you need to discuss the situation.

30. You say that selling your products to new accounts is a major management goal. Please describe your efforts in this regard and discuss how successful they have been to date. The discussion should be quantified to the extent practicable.

Our Company`s ability to continue as a going concern is contingent upon its ability to secure additional financing, increase ownership equity and attain profitable operations... - page 5

31. Please quantify the information in this risk factor. For example, disclose the amount of your accumulated deficits and the amount of the settlement.

32. You state that your ability to continue as a going concern "must be considered in light of the problems, expenses and complications frequently encountered in established markets and the competitive environment in which our Company operates." This statement is too vague and abstract to be meaningful to an investor. Please revise the discussion to explain, in reasonable detail, what these problems, expenses and complications are, and how you have been adversely affected in the past.

If our Company loses key management personnel, it may not be able to successfully operate its business. - page 5

33. Please discuss whether you have employment agreements with the named individuals, and indicate whether you have any reason to believe that you might lose their services.

34. You say that the loss of "certain" of your key employees could adversely affect your operating results or financial condition. Please revise the disclosure to identify the "certain" employees and describe how your operating results or financial condition would be adversely affected.

There are a limited amount of clinical studies and scientific review of our Company`s key products, and our Company`s business could suffer from adverse publicity concerning our Company`s products or similar products. - page 6

35. Please expand the risk factor to indicate whether your products have, to date, been asserted to have caused, or proven to cause harm to consumers. Also disclose whether your products, or similar products, have received adverse publicity to date. If so, please describe the specific adverse consequences that resulted.

Our Company depends on the performance of a network of distributors and brokers. - page 6

36. Please revise the risk factor to provide an adequate factual context for evaluating the risk. For example, how many distributors/brokers do you have? Do any of them account for more than 10% of your revenue? If so, identify them. Have you lost any of them during the past two years? Have you added additional ones during the same period? Do you have any reason to believe that you will lose any of

Show Raw Text
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>

Mail Stop 0309

									February 16, 2005

Mr. Paul Mitchell, President
Med Gen, Inc.
7284 W. Palmetto Park Road - Suite 207
Boca Raton, Florida  33433

Re:  	Med Gen, Inc.
Form SB-2 Registration Statement
	File No. 333-122093

	Form 10-KSB for the fiscal year ended September 30, 2004
	Form 10-QSB for the period ended December 31, 2004
	File No. 0-29171

Dear Mr. Mitchell:

      We have reviewed your filing and have the following
comments.
Where indicated, we think you should revise your document in
response
to these comments.  If you disagree, we will consider your
explanation as to why our comment is inapplicable or a revision is
unnecessary.  Please be as detailed as necessary in your
explanation.
In some of our comments, we may ask you to provide us with
supplemental information so we may better understand your
disclosure.
After reviewing this information, we may or may not raise
additional
comments.

      Please understand that the purpose of our review process is
to
assist you in your compliance with the applicable disclosure
requirements and to enhance the overall disclosure in your filing.
We look forward to working with you in these respects.  We welcome
any questions you may have about our comments or on any other
aspect
of our review.  Feel free to call us at the telephone numbers
listed
at the end of this letter.

Comments applicable to the entire filing

1. Throughout the document you have improperly capitalized many
words
and terms that you are using for their common meanings.  They
include
the following:  "Company," "Prospectus," "Investors," "Offering,"
"Common Stock," "Pink Sheets," and "Annual Report."  Please revise
your document to limit use of capitalization to proper names and
the
first letters of sentences.

2. Throughout your document, you have made excessive use of the
phrase "our Company,"  a term that is too vague and generic to be
meaningful.  Instead, please replace this term with words such as
Med
Gen, we, our, us or similar language that is more precise and
descriptive.

Prospectus Cover Page

3. Information presented on the cover page should be limited to
the
information specified in Item 501(a) of Regulation S-B.
Accordingly,
please delete all but the portion of the first sentence of the
first
paragraph up to the comma, the second paragraph, all but the first
sentence of the third paragraph and the fourth paragraph.  You
should
also expand the disclosure regarding your stock price to include
the
asked price and to indicate that the prices may not reflect any
actual transactions.

4. Please revise the cross reference to the risk factor section so
that it is in bold face type.

Prospectus Summary

5. Please delete the last sentence of the introductory paragraph.
This information is clear, or should be clear from the context.

6. Although you refer to this section as a "summary" of
information
contained elsewhere in the document, as currently written, it does
not summarize any information at all.  Instead, it simply repeats
information you already provided on the cover page.  If you choose
to
include a summary in your filing, the information in it should
include a brief overview of your business and the offering.
Please
revise it accordingly.

Risk Factors - page 2

7. In this section and elsewhere in the registration statement you
state that you "cannot assure you that," "there can be no
assurance
that," "there is no assurance that," and "cannot predict whether"
various things will or will not happen.  Statements such as these
are
legalistic and redundant.  Please delete them.  Instead, please be
certain that you have adequately explained why you cannot make the
assurance or prediction.

8. Additionally, describe the consequences if the event(s) that
you
cannot assure or predict will occur do not occur.  For example:

* On page 2, you state that you cannot assure investors that any
institution will be acting as a market maker for your stock at any
time.  Please revise to discuss the consequences if there are not
market makers.

* On page 4, you state that you can`t assure investors that they
will
ever receive any cash, stock or other dividends on their shares.
Please revise to discuss the consequences.

9. Many of your risk factor subheadings are simple statements of
fact
that do not identify a specific risk and its potential adverse
consequences to an investor or the company.  You will need to
revise
them so that they do.  In addition, the subheading should
accurately
summarize the content of the body of the risk factor.  The
subheading
should not be repeated in the body of the risk factor.  Here are
some
examples of subheadings that need to be revised:

* "Our Company does not plan to issue dividends to its
stockholders
for the foreseeable future." - page 4

* "Our Company faces competition, and many of its competitors are
larger and have more resources than our Company." - page 4

* "Our Company`s success is dependent upon its ability to manage
anticipated growth." - page 5

* "Our Company depends on the performance of a network of
distributors and brokers." - page 6

There is a limited trading market for our Company`s stock, which
may
cause our Company`s reported stock prices to be volatile and limit
your ability to sell your shares. - page 2

10. It appears that you have combined two separate risks in this
risk
factor.  One relates to your trading on the OTC Bulletin Board and
the other relates to the market for stocks of OTC "wellness"
companies.  Please separate the risks so that each one is
presented
under an appropriate subheading.

11. Please delete the first sentence of the risk factor as it
simply
repeats information you already provided on the cover page.  The
second sentence is a mitigating statement that is inappropriate in
a
risk factor, and should also be deleted.

In the event that the price of our Company`s stock is less than
$5.00
per share, as it currently is, our stock will be subject to the
requirements for penny stocks, which could adversely affect your
ability to sell and the market price of your shares. - page 3

12. As there is no indication that your stock price has ever been
over $5.00, nor any indication that it is likely to be so in the
foreseeable future, we think this subheading is inappropriately
mitigating as it is currently written.  We think it would be more
appropriate to state that the stock is a "penny stock" under the
federal securities laws, and as such, is subject to special
trading
rules that are likely to make it difficult to sell your shares at
a
price higher than an investor paid for them.

13. In the last sentence of the risk factor you refer to
restrictions
on the resale of the shares being registered.  We do not
understand
what you are trying to say.  Registered shares are supposed to be
freely tradeable.  Are you saying that the shares are subject to
some
additional restrictions?  If so, you will need to disclose them.

In the future, our revenues and quarterly operating results may
fluctuate, which may adversely affect the market price of our
Company`s stock and could lead to our Company becoming the target
of
costly securities class action litigation. - page 3

14. Please delete the phrase "in the future" from the subheading.
It
suggests that you have not had such fluctuations in the past.

15. In the body of the risk factor you refer to the "expectations
of
market analysts."  Are your shares currently being followed by
market
analysts?  If so, please provide us with copies of these current
analyses.  If not, please delete the references to analysts.

16. As currently written, this risk factor could be discussing any
company in your industry.  Please revise it to more specifically
describe your own situation.  For example, we note the large drop
in
your revenue during the past year.  How did this drop impact your
stock price?  Did you add any new products to your line?  If so,
how
did that affect your stock price.  The disclosure should also be
quantified to the extent practicable.

You may suffer dilution of your investment if our Company issues
additional securities; our Company has in the past and may in the
future issue securities to its executive officers and directors. -
page 4

17. Currently, both the subheading and the body of the risk factor
are statements of fact that do not identify a specific risk and
its
potential adverse consequences.  Please revise the risk factor
accordingly.  Also, you need to include a factual context for
analyzing the risk.  How many securities have you issued in each
of
the last two years and interim period?  Who did you issue them to?
What percentage of your outstanding shares do these issuances
represent?  How did these issuances affect the market for your
shares?

Our Company does not plan to issue dividends to its stockholders
for
the foreseeable future. - page 4

18. The subheading and the body of this risk factor are also
statements of fact that do not describe a specific risk and its
likely adverse consequences.  Please revise it accordingly.  In
light
of your going concern opinion, we are not sure why a person making
an
investment in your company at the present time would consider the
non-issuance of dividends to be a significant risk.  Please
explain
in your revised disclosure.

Our company`s articles of incorporation and bylaws contain
provisions
that could delay or prevent a change in control.  These provisions
could limit the price that investors might be willing to pay in
the
future for shares of the Company`s common stock. - page 4

19. Please revise and expand the risk factor to be more specific.
For example, is it an article of incorporation, a bylaw or a
statute
that permits you to issue preferred stock as stated in the first
bullet.  What is the supermajority voting requirement?  What is
the
percentage of stock controlled by management?  Does the
supermajority
requirement enable management to veto transactions that may be
desired by other non-affiliated shareholders?

20. It appears that these provisions also serve to entrench
current
management of the company.  Please include appropriate risk factor
disclosure regarding this.

Through this Offering, our Company is registering a significant
number of shares of common stock so that they are freely tradable,
which may have a depressing effect on the market price of the
common
stock of our Company. - page 4

21. Currently, this risk factor makes a statement, but does not
describe a specific risk and its potential adverse consequence for
a
person investing in this offering.  Moreover, the body of the risk
factor simply repeats the statement in the subheading.  Please
revise
the risk factor and its subheading to describe a specific risk and
its potential adverse consequences.  Also, provide an adequate
factual context, quantified to the extent practicable, for
analyzing
the risk.

Our Company faces competition, and many of its competitors are
larger
and have more resources than our Company. - page 4

22. Please revise the risk factor and its subheading to describe a
specific risk and its potential adverse consequences for an
investor
in this offering.  Include an adequate factual context as well.
For
example, who are your primary competitors?  How does your market
share compare to theirs?  On what basis do you compete with them?
How has your lack of financial resources affected your ability to
compete?  Has your consent decree with the FTC affected how you
compete?  How much do you anticipate it will cost you to
effectively
compete?

23. In the risk factor you state that you have "entered the magnet
therapy market."  We are unable to locate a discussion of this in
the
business section or MD&A.  Please provide the appropriate
disclosures
regarding this activity, including an explanation of what it is,
how
much funding you will need to do this, and how you propose to
obtain
the funding.

Our Company`s success is dependent upon its ability to manage
anticipated growth. - page 5

24. You state in the risk factor that your company intends to
pursue
"rapid growth."  Please explain, in light of your current
financial
condition, how you propose to do this.  Quantify the disclosure to
the extent practicable.  Your revised disclosure should also be
specific about what the term "rapid growth" means for your
business.

25. As currently written, the risk factor is so vague and abstract
that it could apply to any company.  Please revise it to be
specific
to your own situation.

In fiscal year 2004, our Company`s three largest customers were
Wal-
Mart, Walgreens and Eckerd which represented 66% of our Company`s
annual sales that year... - page 5

26. Please revise the subheading and body to describe a specific
risk
and its potential adverse consequence.  Also, delete the first
sentence of the body of the risk factor since it simply repeats
the
subheading.

27. Disclose when you introduced the new brand and the percentage
of
revenue attributable to it.

28. Explain what you mean when you refer to "the issue of
dominance"
and how introducing a new product addresses it.

29. Do you have any reason to believe that you will lose any of
your
material customers?  If so, you need to discuss the situation.

30. You say that selling your products to new accounts is a major
management goal.  Please describe your efforts in this regard and
discuss how successful they have been to date.  The discussion
should
be quantified to the extent practicable.

Our Company`s ability to continue as a going concern is contingent
upon its ability to secure additional financing, increase
ownership
equity and attain profitable operations... - page 5

31. Please quantify the information in this risk factor.  For
example, disclose the amount of your accumulated deficits and the
amount of the settlement.

32. You state that your ability to continue as a going concern
"must
be considered in light of the problems, expenses and complications
frequently encountered in established markets and the competitive
environment in which our Company operates."  This statement is too
vague and abstract to be meaningful to an investor.  Please revise
the discussion to explain, in reasonable detail, what these
problems,
expenses and complications are, and how you have been adversely
affected in the past.

If our Company loses key management personnel, it may not be able
to
successfully operate its business. - page 5

33. Please discuss whether you have employment agreements with the
named individuals, and indicate whether you have any reason to
believe that you might lose their services.

34. You say that the loss of "certain" of your key employees could
adversely affect your operating results or financial condition.
Please revise the disclosure to identify the "certain" employees
and
describe how your operating results or financial condition would
be
adversely affected.

There are a limited amount of clinical studies and scientific
review
of our Company`s key products, and our Company`s business could
suffer from adverse publicity concerning our Company`s products or
similar products. - page 6

35. Please expand the risk factor to indicate whether your
products
have, to date, been asserted to have caused, or proven to cause
harm
to consumers.  Also disclose whether your products, or similar
products, have received adverse publicity to date.  If so, please
describe the specific adverse consequences that resulted.

Our Company depends on the performance of a network of
distributors
and brokers. - page 6

36. Please revise the risk factor to provide an adequate factual
context for evaluating the risk.  For example, how many
distributors/brokers do you have?  Do any of them account for more
than 10% of your revenue?  If so, identify them.  Have you lost
any
of them during the past two years?  Have you added additional ones
during the same period?  Do you have any reason to believe that
you
will lose any of