SEC Comment Letter for Global Clean Energy Holdings, Inc. (GCEH) (CIK 0000748790) — Jan 21, 2005
Global Clean Energy Holdings, Inc. (GCEH) (CIK 0000748790)
Date: Jan. 21, 2005 · CIK: 0000748790 · Accession: 0000000000-05-003315
AI Filing Summary & Sentiment
File numbers found in text: 333-121635
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Mail Stop 0309
January 21, 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. 1 to Form SB-2 Registration Statement filed on
December
30, 2005
File No. 333-121635
Dear Ms. Robinett:
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.
Registration Fee Table
1. Footnote 1 to the prospectus summary indicates that the number
of
shares being registered includes a number of shares issuable upon
conversion of a "contingent issuance of Series A convertible
preferred stock." We understand that 60,000,000 of the
113,511,158
shares being registered are allocated to shares underlying this
contingent issuance of stock. You also state that the sale of the
preferred stock is contingent on you entering into and closing a
definitive agreement to purchase "certain assets in a proposed
acquisition, the details of which have not yet been disclosed and
regarding which no definitive agreement is yet executed." Please
provide us with your analysis explaining why registration of these
shares is appropriate at the present time. Also, please file the
subscription and/or purchase agreements for all of the shares
being
registered, as exhibits to this registration statement. The
material
terms of these agreements should be disclosed and discussed at an
appropriate place in the prospectus.
Prospectus Cover Page
2. Please limit the disclosure on your cover page to the
information
specified in Item 501(a) of Regulation S-B. For example, please
replace the first paragraph with a sentence indicating that you
are
registering ____ shares for resale by the selling shareholders
identified on page___ of the prospectus. None of the remaining
information in that paragraph is information specified in Item
501(a).
3. Please eliminate your address and phone number on the cover
page.
Where you include them under the caption "Our Company" in the
prospectus summary, please also include your web address.
Table of Contents Page
4. Please delete the last sentence of the paragraph below the
table
of contents as there is no information incorporated by reference
in a
Form SB-2 registration statement.
Summary
5. In a number of places in your document you have used technical
language or jargon that is not likely to be understood by your
readers. Please replace them with a "plain English" term. If you
cannot convey the meaning without them, please explain what the
term
means at the first place they appear. Here are some examples of
the
type of language that you should either replace or explain.
* Patented anti-infective technology
* Electrolyzed solution of free radicals
* Cell-based assays
* Anti-infective therapeutic product for in-vitro and in-vivo
applications
Risk Factors - page 2
6. In your risk factors, and other places in your document, you
use
phrases such as "we can give you no assurance that" and "there can
be
no assurance that" various things will or will not happen. This
language is legalistic and redundant. Please delete these and
similar phrases and instead, be sure that you have adequately
explained why you cannot, assure these things.
Our operations are and will be subject to extensive government
regulation. - page 4
7. The information you included in this risk factor, which
continues
over three pages, is too detailed for risk factor disclosure.
Please
revise it to include a description of the risk and its
consequences
and enough additional information to put the risk into context.
If
you are discussing multiple risks under one heading, break them
out
into separate risk factors. The remainder of the information
should
be disclosed in the business section of the document.
8. Currently, the last sentence of the risk factor states that you
have not completed all testing necessary to prepare and submit an
IND
to the FDA, and that you do not have the financial resources
necessary to do so. However, on the first page of the Summary,
you
state that you filed an IND with the FDA on November 1, 2004 and
that
you expect to file a second one in early 2005. Please reconcile
these inconsistencies.
Our intellectual property may not be adequately protected. - page
7
9. Please be more specific about what your patents cover. For
example, do they cover the substance of MDI-P, or do they cover
specific uses of that substance? What is the duration of your
patents? How many do you have? Currently, the information in
your
risk factor is too generic and ambiguous to be meaningful to an
investor. Also, what do you mean when you say that your
technology
"is not necessarily novel?" Do you have the funds to prosecute
patent infringements? Are you aware of any infringements? You
need
to expand the risk factor to provide enough facts for an investor
to
analyze the risk.
We face significant product liability. - page 8
10. Please revise the risk factor to clearly indicate whether you
currently have liability insurance. If you do, please disclose
the
amount and extent of the coverage. If you don`t, please disclose
whether you have adequate funds to obtain coverage, whether you
have
been denied coverage, and the consequences for the clinical trials
you are beginning.
Selling Security Holders - page 10
11. Please revise to include the identities of the natural persons
having beneficial ownership of the securities registered for sale.
Also, tell us whether any of them are broker/dealers or are
affiliated with broker/dealers.
Directors, Executive Officers, Promoters and Control Persons -
page
14
12. Please expand the information regarding Mr. Anderson to more
specifically his business experience during the past five years.
13. Please provide factual support for the claim made in the fifth
sentence of the description of Dr. Dezube`s experience. In the
alternative, it should be deleted.
14. Please provide factual support for the claim made in the
second
sentence of the description of Dr. Mastico`s experience. In the
alternative, it should be deleted.
15. In the last sentence of Dr. Palmer`s description, please
explain
what an "NDEA Title IV fellow" is.
Security Ownership of Certain Beneficial Owners and Management -
page
16
16. If your outstanding preferred stock is currently convertible,
or
will become convertible within the next 60 days, please provide
ownership information for it in the table on an "as converted"
basis.
Please revise or advise as appropriate.
Preferred Stock, page 17
17. You state that the Series A preferred stock has a dividend
preference but do not describe it. Usually preferred shareholders
acquire a dividend preference because they are designated the
payment
of a dividend which must be paid prior to the payment of dividends
on
commons shares. Please revise to disclose the specific dividend
preference. Similarly, you state that the preferred shareholders
are
entitled to a return of their original investment upon dissolution
of
the registrant. Please quantify what holders of outstanding shares
of
preferred stock are entitled to upon dissolution of the company.
Related Party Transactions, page 19
18. You state that the registrant has accrued a total of $879,136
payable to Ms. Robinett for services rendered and expenses accrued
on
behalf of the company. It is not clear as to whether these
amounts
include the accrued and unpaid salary referred to in the executive
compensation table or are in addition to it. Please provide
additional disclosure. Also, on page 21 under the caption entitled
"Employees", you state that the registrant has no employees and
that
Ms. Robinett is an independent contractor. This suggests that Ms.
Robinett does not receive a salary. Please reconcile the
disclosure
in all three of these sections of the prospectus.
19. Please break out the amounts accrued for services rendered and
for expenses accrued, separately. Also, identify the nature of the
services and expenses and disclose the period of time over which
they
were rendered or accrued, respectively.
20. File the agreement(s) regarding the compensation of Ms.
Robinett
by the company as exhibit(s) to the registration statement and
describe the terms whereby she is compensated for services
rendered
and expenses accrued. If there are no written agreements describe
the
terms of any oral agreements between the registrant and Ms.
Robinett.
Description of Business - page 19
21. Please include a discussion of the sources and availability of
raw materials needed to make your product, and the names of your
principal suppliers.
22. Please provide support for the statement in the third
paragraph
of this section where you indicate that you believe you have
sufficient capital to complete Phase I of your cystic fibrosis
trials.
23. Please expand the discussion of your patents on page 20 to
include such information as the duration of the patents and
whether
they are use patents for a previously patented substance, or a
patent
for the substance. You also need to discuss their adequacy for
protecting your proposed indications for use.
Executive Compensation - page 26
24. Please update the information through the fiscal year ended
December 31, 2004.
Financial Statements - December 31, 2003
Independent Auditors` Report, page F-2
25. We note that you make reference to the predecessor auditor for
their work performed from inception (November 20, 1991) through
December 31, 1999. If it is your preference to continue to make
such
reference, please provide their audit report and related consent.
Refer to rule 2-05 of Regulation S-X.
Consolidated Statements of Operations, F-4
26. Please reclassify all forgiven debt that has been under
extraordinary item since inception to other income in accordance
with
paragraph 10 of SAFS 145.
Notes to Financial Statements, page F-8
Note A - Significant Accounting Policies, page F-8
Other Income, page F-10
27. Please tell us the amount of and clarify for us forgiven debt
for
those liabilities that were "uncollectible by the creditor for a
variety of reasons" as to how you were legally released by the
creditors which is required by paragraph 16 of FAS 140 before a
liability can be considered extinguished. Further, please
separately
quantify for us the amounts that relate to forgiven debt that was
"inaccurately booked" and tell us how you determined the
adjustment
for these liabilities was not a correction of error that requires
restatement of prior financial statements.
Note G - Stock Purchase Warrants, page F-13
28. We note that there was a change in the terms of certain
warrants
outstanding. Please include a discussion of the accounting
consequences of this change and when it occurred. Supplementally,
tell us the accounting literature supporting your treatment.
Signatures
29. Please identify and provide the signature of the controller or
chief accounting officer.
* * * * *
As appropriate, please amend your registration statement in
response
to these comments. You may wish to provide us with marked copies
of
the amendment to expedite our review. Please furnish a cover
letter
with your amendment that keys your responses to our comments and
provides any requested supplemental information. Detailed cover
letters greatly facilitate our review. We may have additional
comments after reviewing your amendment and responses to our
comments.
We urge all persons who are responsible for the accuracy and
adequacy
of the disclosure in the filings reviewed by the staff to be
certain
that they have provided all information investors require for an
informed decision. Since the company and its management are in
possession of all facts relating to a company`s disclosure, they
are
responsible for the accuracy and adequacy of the disclosures they
have made.
Notwithstanding our comments, in the event the company requests
acceleration of the effective date of the pending registration
statement, it should furnish a letter, at the time of such
request,
acknowledging that
* should the Commission or the staff, acting pursuant to delegated
authority, declare the filing effective, it does not foreclose the
Commission from taking any action with respect to the filing;
* the action of the Commission or the staff, acting pursuant to
delegated authority, in declaring the filing effective, does not
relieve the company from its full responsibility for the adequacy
and
accuracy of the disclosure in the filing; and
* the company may not assert this action as a defense in any
proceeding initiated by the Commission or any person under the
federal securities laws of the United States.
In addition, please be advised that the Division of Enforcement
has
access to all information you provide to the staff of the Division
of
Corporation Finance in connection with our review of your filing
or
in response to our comments on your filing.
We direct your attention to Rules 460 and 461 regarding requesting
acceleration of a registration statement. Please provide this
request at least two business days in advance of the requested
effective date and allow adequate time after the filing of any
amendment for further review before submitting a request for
acceleration.
You may contact Keira Ino at 202-824-5488 or James Rosenberg at
202-
942-1803 if you have questions regarding comments on the financial
statements and related matters. Please contact Mary K. Fraser at
202-942-1864 or me at 202-942-1840 with any other questions.
Regards,
Jeffrey P. Riedler
Assistant Director
cc: Stephen R. Drake, Esq.
Epstein, Becker & Green, P.C.
150 N. Michigan Avenue, Suite 420
Chicago, Illinois 60601
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Judy M. Robinett
Medical Discoveries, Inc.
January 21, 2005
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