February 14, 2006 |
Re:
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Form
SB-2 filed August 1, 2005
Amendment
No. 2 to Form SB-2 filed January 9, 2006
File
No. 333-127071
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1.
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Please
clarify throughout what “cGMP” means and who or what authority the
guidelines come from.
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2.
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The
company’s preferred dividend obligation should be discussed in MD&A
under Liquidity and Capital Resources. Any arrearages should be
indicated.
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3.
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Please
remove what appear to be tags of some sort (<R>) throughout
the unmarked EDGAR version of the
filing.
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4.
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The
first risk factor refers to an inception date of April 26, 2002,
which
appears to be in error; it should reconcile with that used in the
financial statements.
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5.
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As
previously requested, since none of the persons listed annual salary
and
bonus exceeded $100,000, clarify the reference to compensation of
“$100,000 or more” in the first paragraph. Refer to Item 402(a)(2) of
Regulation S-B for the persons required to be
listed.
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6.
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In
addition, please update all disclosure hereunder for the most recent
fiscal year.
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7.
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The
references to “donees, pledgees, transferees or other
successors-in-interest” should be removed or a statement added that the
identities of such persons will be added by post effective
amendment.
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8.
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We
note your response to prior comment 27. Please expand the APB
20
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disclosures
in Note 2 on page F-9 and Note 6 on page F-28 to show the amount
and
nature of each material revision. For example, expand the line
item,
“additional stock-based compensation” to disclose the effect of revisions
including:
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·
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expense
recognition for the Trilogy
warrants,
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·
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expense
resulting from the use of quoted market
price,
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·
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the
application of EITF 96-18 to options granted to
non-employees.
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9.
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We
note your response to prior comment 30. While the agreement may
provide
that the liquidated damages are required to be paid in cash,
the ability
to have the registration statement declared effective remains
outside of
the control of the issuer. We note that the liquidated damages
are
material and appear to be potentially unlimited, which renders
the
settlement option of providing unregistered shares to settle
the warrants
uneconomic. Accordingly, we believe the warrants are required
to be
initially classified as liabilities under EITF 00-19, and then
adjusted to
fair value at each subsequent balance sheet date, with changes
in fair
value reflected in the statement of operations. See paragraphs
14-17 of
EITF 00-19. Please revise your financial statements and related
disclosures
accordingly.
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10.
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We
note your response to prior comment 42. Please revise the
statement of
stockholders’ equity and the calculation of net loss per share applicable
to common shareholders to reflect the dividend, or tell us
why you believe
that no revisions are
required.
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11.
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In
your amended filing, please revise to include the new undertakings
that
became effective on December 1, 2005. See Questions 3 through
6 in
Securities Offering Reform Transition Questions and Answers,
which is
available on our web site at http://www.sec.gov/divisions/corpfin/transitionfaq.htm.
See new Item 5l2(a)(4) and 512(g) of Regulation S-B, which
were adopted in
Securities Offering Reform, Release No. 33-8591 (July 19, 2005),
which is
available on our web site at http://www.sec.gov/rules/final/33-8591fr.pdf.
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12.
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Please
have your Chief Financial Officer and Chief Accounting Officer
sign in
those
capacities.
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13.
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We
note your response to prior comment 27. We also note that
no filings were
made under Item 4.02 of Form 8-K relating to the various
restatements.
Please file the required disclosures under Item 4.02 of Form
8-K as soon
as
possible.
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14.
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We
note your disclosure under Item 307 of Regulation S-B in
each amended
periodic report concludes your disclosure controls and procedures
were
effective. Please tell us the specific factors you considered
in
determining your disclosure controls and procedures were
effective, in
light of the restatements to your financial statements disclosed
in Note 2
to the financial statements for the year ended January 31,
2005, and in
Note 6 to the financial statements for the six months ended
July 31,
2005.
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Very truly yours,
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/s/
Jeffrey J. Fessler
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