SEC Comment Letter for Global Clean Energy Holdings, Inc. (GCEH) (CIK 0000748790) — Jul 1, 2005
Global Clean Energy Holdings, Inc. (GCEH) (CIK 0000748790)
Date: July 1, 2005 · CIK: 0000748790 · Accession: 0000000000-05-033890
AI Filing Summary & Sentiment
File numbers found in text: 333-121635
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<TYPE>LETTER
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Mail Stop 0309
June 30, 2005
Judy M. Robinett
President and Chief Executive Officer
Medical Discoveries, Inc.
1338 S. Foothill Drive - #266
Salt Lake City, Utah 84108
Re: Medical Discoveries, Inc.
Amendment No. 2 to Form SB-2 Registration Statement
File No. 333-121635
Dear Ms.Robinette:
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.
General
1. Your letter of response indicates, with respect to most of the
comments in our previous letter, only that "the prospectus has
been
revised in response to the Staff`s comments." When you respond to
the comments in this letter, please indicate, in each response,
precisely where the revisions are located and, in reasonable
detail,
what they consist of.
2. We note that you have made a number of revisions to your
previously filed document that have not been red-lined in this
amendment. See, for example, the footnotes now presented on pages
1
and 2 and the footnotes to the selling security holders table on
page
12. Please ensure that all revisions are red-lined in future
amendments to this registration statement.
3. We are unable to locate the disclosure required by Item 402 of
Regulation S-B. Please include it in your next amendment.
Prospectus Summary - page 1
4. Please revise the disclosure under "Our Company" to disclose
the
exact developmental status of each of your proposed products.
5. It appears that there is no minimum conversion price per share
on
the convertible preferred stock you issued on March 14, 2005.
Please
clearly indicate this and include appropriate disclosure here, and
in
the risk factor section, regarding the potential adverse
consequences
for investors.
6. Also, please tell us why you used a $.05 per share conversion
price to determine the number of shares underlying the convertible
preferred stock issued in March if there is not a minimum
conversion
price.
7. Please disclose the maximum and minimum number of shares that
could be issued on conversion of all of the convertible preferred
stock.
Risk Factors - page 2
8. Please include a risk factor addressing "penny stock" issues.
9. Please include a risk factor addressing the risks and adverse
consequences resulting from the beneficial ownership of 80.58% of
your common stock by Mercator Advisory Group, LLC.
We are a development-stage company that has not yet commercialized
a
product. - page 2
10. In the third sentence of the risk factor you characterize your
pre-clinical studies of MDI-P and SaveCream as "quite favorable."
It
is unclear what this statement means, especially in the pre-
clinical
context. In addition, it appears to be mitigating language that
is
inappropriate in risk factor disclosure. Please delete it.
11. In addition, we are unable to locate any disclosure in the
document relating to pre-clinical studies of SaveCream. Please
either delete the reference or provide the information supporting
the
statement.
We may not be able to raise sufficient capital to meet present and
future obligations. - page 3
12. You indicate that as of March 31, 2005, your current
liabilities
exceeded your current assets by $760,802 and you need to obtain
additional capital to meet "basic operational needs." Please
identify and quantify these needs. Discuss the steps you have
taken
or intend to take to remedy this situation. Identify the specific
adverse consequences that you will experience if you are unable to
satisfy your current liabilities or operational needs.
13. On page 22 you indicate that you have filed an IND with the
FDA
seeking permission to begin Phase I human clinical trials of MDI-P
as
a treatment for cystic fibrosis, and the FDA has requested further
animal testing and raised other questions. Please address the
effect
your financial condition has and will have on your IND application
as
part of this risk factor.
14. In the fourth sentence of the risk factor you state that you
do
not anticipate that revenues will satisfy these capital
requirements.
This suggests that you currently have revenues, which is not the
case. Please delete the statement.
15. In the last bullet of the risk factor you refer to "the effect
of
the exercise of outstanding options and warrants exercisable into
approximately 60 million shares of common stock." Please describe
what this effect is likely to be.
Our operations are and will be subject to extensive regulation. -
page 4
16. Please refer to comment 8 in our previous letter. In that
comment we asked you to reconcile a number of statements regarding
submission of an IND to the FDA. Your response indicates that you
revised the prospectus in response to the comment, but we are
unable
to locate the revised disclosure. Please tell us where to find
the
revised disclosure, or provide us with the information we
previously
requested
We face intense competition and competing products. - page 6
17. The information in this risk factor is so vague and abstract
that
it is applicable to most companies in your industry. Please
expand
the risk factor to identify your most significant competitors and
the
competing products for each of your proposed drugs. Discuss how
you
propose to compete with these competitors and products given your
limited resources.
Our intellectual property may not be adequately protected. - page
6
18. Please refer to comment 9 in our previous letter. Your
revised
risk factor does not address most of the issues we raised in that
comment. Please revise the risk factor as we previously
requested.
We may need to litigate to secure our rights to SaveCream and
related
assets. - page 7
19. You say that at the time you acquired SaveCream, the seller
had
not yet obtained and filed with the appropriate patent offices
assignments of the various inventors` rights to the underlying
inventions. Please expand the risk factor to identify the patent
offices, inventors, inventors` rights and underlying inventions
you
refer to.
20. You say further that you may need to initiate litigation
against
the inventors to secure the assignments. Please indicate what
country you would have to litigate this issue in, whether you
currently have the funds to do so, and whether the inventors have
refused to make the assignments. If so, also indicate what the
basis
for their refusal is.
21. It is unclear whether the failure to obtain the assignments
means
that the intellectual property you acquired in this transaction is
not patentable, or whether patent applications have even been
filed.
We may have additional comments after we review your response.
The market for our stock is thin and subject to manipulation. -
page
8
22. Please revise the risk factor to discuss the "thin" trading in
your stock as well as the potential for "manipulation" referenced
in
the subheading. Quantify the disclosure to the extent
practicable.
Obtaining additional capital though the sale of common stock will
result in dilution of stockholder interests. - page 8
23. We note that this risk factor is related to the risk factor
called "We may not be able to raise sufficient capital..." on page
3.
Please relocate it so that it follows that risk factor. Also,
please
tie this risk to the last bullet in the risk factor on page 3.
24. Under "Dilution" on page 10, you discuss the adverse impact
that
outstanding options and conversion rights may have on future
equity
offerings. You should also address this impact in the relocated
risk
factor.
Selling Securityholders - page 10
25. In comment 11 of our previous letter we requested that you
tell
us whether any of the natural persons having beneficial ownership
of
the securities registered for sale are broker/dealers or
affiliates
of broker/dealers. Your letter indicates that the prospectus has
been revised in response to the comment. Please tell us where
this
information is located or provide us with the information we
previously requested.
26. In comment 11, we also asked you to include the identities of
the
natural persons having beneficial ownership of the securities
being
registered. As previously requested, please identify the natural
persons having beneficial ownership of the securities being
registered on behalf of Ascendiant Securities, LLC and Ascendiant
Capital Group, LLC.
27. The revised disclosure at the top of page 12 indicates that
the
table that follows presents information regarding securities
exercisable before June 2, 2005. Please revise the disclosure and
the table to include this information for any securities
exercisable
within 60 days before and after the filing date of the amendment.
Please make a similar revision to the ownership table on page 17.
Security Ownership of Certain Beneficial Owners and Management -
page
17
28. You have not properly disclosed the ownership information for
Mercator Advisory Group, LLC in the table. You have disclosed, on
page 12, that Mercator Advisory Group controls the investments of
the
Monarch Fund and both Mercator Momentum Funds. Thus, the number
of
shares attributed to Mercator Advisory Group in the table should
include all of the shares attributable to each of the funds. It
also
appears that David F. Firestone should be identified in the table
as
the beneficial owner of all of the shares held by the funds and
the
group. Please revise the table and the footnotes accordingly.
29. Currently, the footnotes contain "estimates" of the number of
shares that may be acquired upon exercise of options. Please
revise
the table and the footnotes to show the exact number of shares
that
may be acquired by each named person upon the exercise of their
stock
options.
30. Please also revise the table and the footnotes to show the
exact
number of shares that can be acquired by each named person upon
the
exercise of warrants or the conversion of convertible securities.
Where convertible securities are convertible based on the current
price of your stock, provide the ownership information based on
the
most recent practicable stock price with appropriate calculations
presented in the footnotes. Please make similar changes to the
selling securityholder information on page 10.
Preferred Stock - page 19
31. Please refer to comment 17 in our previous letter. Although
you
state that the prospectus was revised in response to the comment,
we
are unable to locate any information regarding a dividend
preference.
Please revise or advise as we previously requested.
Description of Business - page 22
32. Please delete the third sentence of the third paragraph under
this heading. It is a conclusory statement unsupported by facts.
33. Please also delete the next to last sentence of the first
paragraph under "Related Developments" on page 23. It to is a
conclusory statement unsupported by facts.
34. On page 23, in the third paragraph under "Recent
Developments,"
you state that you expect to expand the clinical trials for
SaveCream
over 2005 and that this will "open the door to commercialization
opportunities" for SaveCream by late 2006. You have not yet filed
an
IND for this proposed product, and you do not appear to have the
funds to do so. Accordingly, these statements are inappropriate.
Please delete them.
35. In the last paragraph on page 23 you state that you have
agreed
with the FDA on a "large animal model protocol" to establish
pharmacological safety with relation to cardiovascular and central
nervous system toxicity" for your pending IND application and
expect
to begin that phase of the testing in the very near future and to
start Phase I clinical trials in cystic fibrosis in the fourth
quarter of 2005. Given your current financial condition and lack
of
funds, it is not clear how you intend to do this. Please identify
the source of funds you will use to do this and how much you
anticipate it will cost. If you are unable to provide this
information, please delete the statements regarding the timing of
your research activities.
36. In a number of places in your revised disclosure you make
claims
regarding the size of markets, side-effects of existing products
and
other statistical claims. See, for example, the third paragraph
on
page 26, the third paragraph on page 27 and the last three
paragraphs
on page 29. Please provide us with factual support for each claim
you make, including copies of the documents you are relying on in
making the claims. Mark the supporting documents to show the
specific location of the information underlying each claim. We
may
have further comment after reviewing the supporting documents.
37. Please refer to the bullets at the bottom of page 27. Please
revise this and all other instances where you have stated that
your
proposed products have been shown, demonstrated or otherwise
suggested that any of your product candidates is safe or
effective,
including the last sentence on page 28 and the last sentence of
the
carryover paragraph at the top of page 29 and all of the
disclosure
under "Potential Benefits of SaveCream in Treating ER-Positive
Breast
Cancers" on page 30. These conclusions are for the FDA or similar
foreign regulatory authority to make. Additionally, when
referring
to the FDA or other regulatory authority`s finding you should
state
that the candidate is sufficiently safe or effective as they do
not
declare a product to be safe. We will note object if you disclose
that a candidate was well tolerated or demonstrated positive
results.
38. Please refer to comment 22 in our previous letter. We are
unable
to locate the revised disclosure. Please advise us where it is
located or revise as we previously requested.
39. Please revise your discussion of patents to explain what a
"method patent" is. Also, we are unable to locate the revisions
you
made in response to comment 23, except for the duration of the
patents. Please provide the remainder of the information we
requested in that comment.
Management`s Discussion and Analysis - page 37
Liquidity and Capital Resources - page 38
40. In the second paragraph under this heading you refer to making
"the second installment on our purchase of the SaveCream assets."
We
are unable to locate any discussion of these installment payments
in
conjunction with your description of the acquisition. Please
discuss
your purchase arrangement in greater detail, quantifying the
disclosure to the extent practicable. We may have additional
comments after reviewing your response.
41. We note that your agreement to acquire these assets has not
been
filed as an exhibit to the registration statement. Please include
it
in your next amendment. In addition, please expand the discussion
in
the business section to include a discussion of all of the
material
provisions of that agreement.
42. Please provide factual support for your claim that you have
sufficient capital on hand to complete Phase I clinical trials for
cystic fibrosis. We note, in this regard, that the FDA has not
approved the IND, although it has been pending for an extended
period
of time, and has apparently required yo