SEC Company Response from Akari Therapeutics Plc (AKTX) (CIK 0001541157) (AKTX) — Aug 8, 2012
Akari Therapeutics Plc (AKTX) (CIK 0001541157)
Date: Aug. 8, 2012 · CIK: 0001541157 · Accession: 0001144204-12-043637
AI Filing Summary & Sentiment
Reasoning
File numbers found in text: 000-54749
Letter
Jeffrey Schultz | 212 692 6732 | jschultz@mintz.com
Chrysler Center
666 Third Avenue
New York, NY 10017
212-935-3000
212-983-3115 fax
www.mintz.com
August 8, 2012
Via EDGAR and by Federal Express
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Mail Stop 3561
Washington, D.C. 20549
Re: Morria Biopharmaceuticals PLC
Registration Statement on Form 20-FR12G/A
Filed June 28, 2012
File No. 000-54749
Ladies and Gentleman:
On behalf of Morria Biopharmaceuticals PLC (the “Company”), we hereby file with the Securities and Exchange Commission (the “Commission”) Amendment No. 1 to the Company’s Registration Statement on Form 20-FR12G (the “Amendment”), as originally filed with the Commission on June 28, 2012. We are also delivering five clean and marked complete courtesy copies of the Amendment to the attention of Jeffrey Riedler, Esq. Assistant Director of the Commission.
Set forth below are the Company’s responses to the Commission’s comments provided by a letter (the “Comment Letter”) dated July 25, 2012, from the staff at the Commission (the “Staff”). The Company’s responses are numbered to correspond to the comments, as set forth in the Comment Letter, which, for convenience, we have incorporated into this response letter. All references to page numbers are to the marked draft of Amendment No. 1.
General
1. Pursuant to section 12(g)(1) of the Exchange Act, your registration statement will become effective by operation of law on August 27, 2012 at which time you will be required to begin filing all of the reports mandated by Section 12(g) of the Securities Exchange Act of 1934. If the review process has not been completed before that date you should consider withdrawing the registration statement prior to August 27, 2012 to prevent it from becoming effective and refiling it at such time as you are able to respond to any remaining issues or comments.
Response: We note the Staff’s comment and will withdraw the registration statement, and subsequently re-file it, if all comments have not been resolved prior to August 27, 2012.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Boston | Washington | New York | Stamford | Los Angeles | Palo Alto | San Diego | London
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Securities and Exchange Commission
August 8, 2012
Page 2
2. Please be advised that your registration statement is concurrently being reviewed by the Office of International Corporate Finance. You will receive comments generated by that Office, if any, at a later date.
Response: We note the Staff’s comment and will await further comments, if any, from the Office of International Corporate Finance.
3. Since you appear to qualify as an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act, please disclose on your prospectus cover page that you are an emerging growth company, and revise your prospectus to:
· Describe how and when a company may lose emerging growth company status;
· Briefly describe the exemption from Section 404(b) of the Sarbanes-Oxley Act of 2002 and update your risk factor on page 33 for this exemption; and
· State your election under Section 107(b) of the JOBS Act:
o If you have elected to opt out of the extended transition period for complying with new or revised accounting standards pursuant to Section 107(b), include a statement that the election is irrevocable; or
o If you have elected to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1), provide a risk factor explaining that this election allows you to delay the adoption of new or revised accounting standards that have different effective dates for public and private companies until those standards apply to private companies. Please state in your risk factor that, as a result of this election, your financial statements may not be comparable to companies that comply with public company effective dates. Include a similar statement in your critical accounting policy disclosures.
Response: We have revised the cover page of Amendment No.1 to reflect that the Company qualifies as an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act (the “JOBS Act”) and have revised Amendment No. 1 to respond to the Staff’s comment. Please see the cover page and pages 33 and 70 of Amendment No. 1.
Item 3. Key Information
A. Selected Financial Data, page 4
4. The identification of some columns of selected financial data as “unaudited” may give an investor the impression that the other columns have been audited. We believe your disclosure in the introductory paragraphs of this section is sufficient to highlight to investors which selected financial data have been derived from audited or unaudited financial statements. Please revise your disclosure to remove any label identifying a column as unaudited.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Securities and Exchange Commission
August 8, 2012
Page 3
Response: In response to the Staff’s comment, we have revised the disclosure to remove any labels identifying a column as unaudited. Please see pages 4 and 5 of Amendment No. 1.
D. Risk Factors, page 5
5. Please expand your disclosure in this section to add a risk factor that addresses the risks resulting from the fact that the report of your independent registered public accounting firm on your financial statements states that your recurring operating losses, negative cash flows and dependence on additional financial support raise substantial doubt about your ability to continue as a going concern. Please include in this risk factor the fact that the auditor’s going concern opinion may have a detrimental effect on your ability to obtain additional funding.
Response: In response to the Staff’s comment, we have added a risk factor on page 7 of Amendment No. 1 advising that the auditor’s going concern opinion may have a detrimental effect on the Company’s ability to obtain additional funding.
“We anticipate that we will incur losses for the foreseeable future and we may never achieve or sustain profitability.” Page 6
6. Please state in this risk factor that your total accumulated deficit as of the end of 2011 was $12,621,000.
Response: We have revised the risk factor at issue and included the disclosure requested by the Staff. Please see page 6 of Amendment No. 1.
“We will require additional capital to fund our operations, and if we are unable to obtain such capital, we will be unable to successfully develop and commercialize our product candidates,” Page 6
7. Please expand your risk factor to
· Include an estimate of your operating expenses, including your research and development costs, for fiscal year 2012;
· Disclose the amount of your existing cash and investment securities;
· Disclose the amount of all compensation that you anticipate deferring; and
· Disclose the material elements of your current contemplated plan for your fiscal year ended December 31, 2012.
Response: We have revised the risk factor at issue and included the disclosure requested by the Staff. Please see page 6 of Amendment No. 1.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Securities and Exchange Commission
August 8, 2012
Page 4
“If we default on our convertible notes, we may lose all of our assets and intellectual property,” page 8
8. Please expand this risk factor to disclose:
· The list of events of default as defined in your Securities Purchase Agreement dated April 3, 2012; and
· That you are required to repay your convertible notes by January 4, 2013, the aggregate amount that you expect to be due as of that date, and that you do not currently have sufficient cash available to repay them.
Response: In response to the Staff’s comment, we have revised the disclosure to include a list of events of default, the repayment date and amount of the convertible notes, and that the Company does not currently have sufficient cash available to repay them. Please see page 8 of Amendment No. 1.
“Our product candidates are still in the early stages of development and remain subject to clinical testing and regulatory approval…” page 10
9. Please expand this risk factor to disclose when you intend to file your IND application for your two product candidates in clinical trials.
Response: In response to the Staff’s comment, we have expanded the disclosure in this risk factor to state when the Company intends to file its IND applications for the two product candidates in clinical trials. Please see page 10 of Amendment No. 1.
“We have not conducted any absorption, distribution, metabolism and excretion (ADME) studies with respect to our clinical and pre-clinical product candidates.” page 15
10. In this risk factor, please include the reason you have yet to perform ADME studies and whether or not you intend to conduct such studies in the future.
Response: In response to the Staff’s comment, we have expanded the disclosure in this risk factor to include the reason why the Company has not yet performed ADME studies and that the Company does intend to conduct such studies prior to final submission to the FDA for drug approval. Please see page 15 of Amendment No. 1.
“If our competitors are better able to develop and market products than any products that we and/or any potential future collaborators may develop . . .,” page 21
11. Please include in this risk factor the names of the companies that you believe will be your principal competitors and those products that you believe will compete with yours at such time as yours enter the marketplace.
Response: In response to the Staff’s comment, we have revised the risk factor to include the name of Anthera Pharmaceuticals, Inc. as a competitor of which the Company is aware and that it has a PLA2 inhibitor currently in Phase 3 clinical trial. Please see page 21 of Amendment No. 1.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Securities and Exchange Commission
August 8, 2012
Page 5
“We depend on third-party suppliers for key raw materials used in our manufacturing processes…” page 22
12. Please include in this risk factor the names of the third-party suppliers you are dependent upon.
Response: In response to the Staff’s comment, we have revised the disclosure in this risk factor to include the names of the third-party suppliers that the Company uses. Please see page 22 of Amendment No. 1.
“Use of third-party manufacturers may increase the risk that we will not have adequate supplies of our product candidates or products.” page 24
13. You disclose that your present or future manufacturing partners may not be able to comply with FDA-mandated current Good Manufacturing Practice regulations or other FDA regulatory requirements. To the extent you are aware that one or more of your current manufacturing partners do not comply with FDA-mandated current Good Manufacturing Practice regulations or other FDA regulatory requirements, please disclose this fact as well as the names of each manufacturing partner that does not comply.
Response: All of the Company’s manufacturing partners are compliant with current Good Manufacturing Practice regulations, and we have revised the disclosure on page 24 of Amendment No. 1 in response to the Staff’s comment to reflect this fact.
“We rely on third parties to conduct our clinical trials, and those third parties may not perform satisfactorily…,” page 25
14. Please include in this risk factor the names of the material contract research organizations that have performed your clinical trials to date.
Response: We have revised the risk factor at issue to include the name of the material contract research organization that performs the Company’s clinical trials. Please see page 25 of Amendment No. 1.
“If we do not establish strategic collaborations, we may have to alter our development plans.” page 25
15. This risk factor is substantially similar to the second one on page 22. Please merge them into a single risk factor in order to avoid repetition in your disclosure.
Response: In response to the Staff’s comment, we have merged the two risk factors at issue into a single risk factor. Please see page 22 of Amendment No. 1.
“We will incur increased costs and demands upon management as a result of complying with the laws and regulations affecting public companies…,” page
16. Please estimate the costs you will incur as a result of complying with public company laws and regulations over the next fiscal year and on an annual basis thereafter.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Securities and Exchange Commission
August 8, 2012
Page 6
Response: In response to the Staff’s comment, we have included disclosure regarding the estimate of costs that the Company will incur as a result of complying with public company laws and regulations over the next fiscal year and on an annual basis thereafter. Please see page 33 of Amendment No. 1.
Item 4. Information on the Company
A. History and Development of the Company
April 2012 Private Placement of Senior Secured Convertible Notes and Warrants, page 38
17. In your “Description of Notes” on page 40 please provide the definition of “material adverse event” in your Securities Purchase Agreement.
Response: In response to the Staff’s comment, we have provided the definition of “material adverse effect” (“material adverse event” was a typographical error). Please see page 40 of Amendment No. 1.
18. In your description of the Registration Rights Agreement on page 40, please disclose the actual date rather than referring to the “Self Filing Effective Date” and describe the payments you will be required to make to your investors if this registration statement is not filed and/or declared effective on a timely basis.
Response: We respectfully refer the Staff to page 38 of Amendment No. 1, where “Self Filing Effective Date” has already been defined. We have, however, in response to the Staff’s comment, amended the disclosure to describe the payments the Company will have to make to its investors if this registration statement is not filed and/or declared effective on a timely basis. Please see page 40 of Amendment No. 1.
B. Business Overview
Product Candidates, page 41
19. Please state here, as well as in your discussion of your clinical pipeline on page 49 and your Overview on page 68, that the clinical trials your two major product candidates have undergone were performed in Israel and South Africa, and not in the United States.
Response: In response to the Staff’s comment, we have revised the disclosures at issue to state that the clinical trials are being conducted in Israel and South Africa. Please see pages 49 and 68 of Amendment No. 1.
20. Please state here and wherever else applicable in your registration statement whether or not you believe your clinical trials have complied with the rules for such trials set forth by the FDA. If they have not, please specify how your clinical trials have differed from those rules.
Response: We have added disclosure in response to the Staff’s comment regarding the Company’s compliance with rules set forth by the FDA regarding the conduct of clinical trials. Please see pages 41, 51 and 52 of Amendment No. 1.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Securities and Exchange Commission
August 8, 2012
Page 7
Steroids and Currently Available Alternatives, page 42
21. In your table on page 44, please indicate in the row describing your product candidates that your studies to date have not advanced beyond Phase 2.
Response: We have revised the table on page 44 of Amendment No. 1 in response to the Staff’s comment to indicate that the studies are currently in Phase 2 clinical trials.
Scientific Background to Inflammation and Our Product Candidates, page 45
22. In this disc
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CORRESP
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filename1.htm
Jeffrey Schultz | 212 692
6732 | jschultz@mintz.com
Chrysler Center
666 Third Avenue
New York, NY 10017
212-935-3000
212-983-3115 fax
www.mintz.com
August 8, 2012
Via EDGAR and by Federal Express
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Mail Stop 3561
Washington, D.C. 20549
Re: Morria Biopharmaceuticals PLC
Registration Statement on Form 20-FR12G/A
Filed June 28, 2012
File No. 000-54749
Ladies and Gentleman:
On
behalf of Morria Biopharmaceuticals PLC (the “Company”), we hereby file with
the Securities and Exchange Commission (the “Commission”) Amendment No. 1 to the Company’s Registration
Statement on Form 20-FR12G (the “Amendment”), as originally filed with the Commission on June 28, 2012. We are
also delivering five clean and marked complete courtesy copies of the Amendment to the attention of Jeffrey Riedler, Esq. Assistant
Director of the Commission.
Set forth below are
the Company’s responses to the Commission’s comments provided by a letter (the “Comment Letter”)
dated July 25, 2012, from the staff at the Commission (the “Staff”). The Company’s responses are numbered
to correspond to the comments, as set forth in the Comment Letter, which, for convenience, we have incorporated into this response
letter. All references to page numbers are to the marked draft of Amendment No. 1.
General
1. Pursuant to section 12(g)(1) of the Exchange Act, your registration statement will become effective
by operation of law on August 27, 2012 at which time you will be required to begin filing all of the reports mandated by Section
12(g) of the Securities Exchange Act of 1934. If the review process has not been completed before that date you should consider
withdrawing the registration statement prior to August 27, 2012 to prevent it from becoming effective and refiling it at such time
as you are able to respond to any remaining issues or comments.
Response: We note the Staff’s comment and will
withdraw the registration statement, and subsequently re-file it, if all comments have not been resolved prior to August 27, 2012.
Mintz, Levin, Cohn, Ferris, Glovsky and
Popeo, P.C.
Boston
| Washington | New York | Stamford | Los Angeles | Palo Alto | San Diego | London
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo,
P.C.
Securities and Exchange Commission
August 8, 2012
Page 2
2. Please be advised that your registration statement is concurrently being reviewed by the Office of International Corporate
Finance. You will receive comments generated by that Office, if any, at a later date.
Response: We note the Staff’s comment and will
await further comments, if any, from the Office of International Corporate Finance.
3. Since you appear to qualify as an “emerging growth company,” as defined in the Jumpstart
Our Business Startups Act, please disclose on your prospectus cover page that you are an emerging growth company, and revise your
prospectus to:
· Describe how and when a company may lose emerging growth company status;
· Briefly describe the exemption from Section 404(b) of the Sarbanes-Oxley Act of 2002 and update
your risk factor on page 33 for this exemption; and
· State your election under Section 107(b) of the JOBS Act:
o If you have elected to opt out of the extended transition period for complying with new or revised
accounting standards pursuant to Section 107(b), include a statement that the election is irrevocable; or
o If you have elected to use the extended transition period for complying with
new or revised accounting standards under Section 102(b)(1), provide a risk factor explaining that this election allows you to
delay the adoption of new or revised accounting standards that have different effective dates for public and private companies
until those standards apply to private companies. Please state in your risk factor that, as a result of this election, your financial
statements may not be comparable to companies that comply with public company effective dates. Include a similar statement in your
critical accounting policy disclosures.
Response: We have revised the cover page of Amendment
No.1 to reflect that the Company qualifies as an “emerging growth company,” as defined in the Jumpstart Our Business
Startups Act (the “JOBS Act”) and have revised Amendment No. 1 to respond to the Staff’s comment. Please
see the cover page and pages 33 and 70 of Amendment No. 1.
Item 3. Key Information
A. Selected Financial Data, page 4
4. The identification of some columns of selected financial data as “unaudited” may give
an investor the impression that the other columns have been audited. We believe your disclosure in the introductory paragraphs
of this section is sufficient to highlight to investors which selected financial data have been derived from audited or unaudited
financial statements. Please revise your disclosure to remove any label identifying a column as unaudited.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo,
P.C.
Securities and Exchange Commission
August 8, 2012
Page 3
Response: In response to the Staff’s comment, we
have revised the disclosure to remove any labels identifying a column as unaudited. Please see pages 4 and 5 of Amendment No. 1.
D. Risk Factors, page 5
5. Please expand your disclosure in this section to add a risk factor that addresses the risks resulting
from the fact that the report of your independent registered public accounting firm on your financial statements states that your
recurring operating losses, negative cash flows and dependence on additional financial support raise substantial doubt about your
ability to continue as a going concern. Please include in this risk factor the fact that the auditor’s going concern opinion
may have a detrimental effect on your ability to obtain additional funding.
Response: In response to the Staff’s
comment, we have added a risk factor on page 7 of Amendment No. 1 advising that the auditor’s going concern opinion may have
a detrimental effect on the Company’s ability to obtain additional funding.
“We anticipate that we will
incur losses for the foreseeable future and we may never achieve or sustain profitability.” Page 6
6. Please state in this risk factor that your total accumulated deficit as of the end of 2011 was
$12,621,000.
Response: We have revised the risk factor at issue and
included the disclosure requested by the Staff. Please see page 6 of Amendment No. 1.
“We will require additional capital to fund our
operations, and if we are unable to obtain such capital, we will be unable to successfully develop and commercialize our product
candidates,” Page 6
7. Please expand your risk factor to
· Include an estimate of your operating expenses, including your research and development costs, for fiscal year 2012;
· Disclose the amount of your existing cash and investment securities;
· Disclose the amount of all compensation that you anticipate deferring; and
· Disclose the material elements of your current contemplated plan for your fiscal year ended December 31, 2012.
Response: We have revised the risk factor at issue and
included the disclosure requested by the Staff. Please see page 6 of Amendment No. 1.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo,
P.C.
Securities and Exchange Commission
August 8, 2012
Page 4
“If we default on our convertible notes, we may
lose all of our assets and intellectual property,” page 8
8. Please expand this risk factor to disclose:
· The list of events of default as defined in your Securities Purchase Agreement dated April 3, 2012;
and
· That you are required to repay your convertible notes by January 4, 2013, the aggregate amount
that you expect to be due as of that date, and that you do not currently have sufficient cash available to repay them.
Response: In response to the Staff’s
comment, we have revised the disclosure to include a list of events of default, the repayment date and amount of the convertible
notes, and that the Company does not currently have sufficient cash available to repay them. Please see page 8 of Amendment No.
1.
“Our product candidates are
still in the early stages of development and remain subject to clinical testing and regulatory approval…” page 10
9. Please expand this risk factor to disclose when you intend to file your IND application for your
two product candidates in clinical trials.
Response: In response to the Staff’s
comment, we have expanded the disclosure in this risk factor to state when the Company intends to file its IND applications for
the two product candidates in clinical trials. Please see page 10 of Amendment No. 1.
“We have not conducted any
absorption, distribution, metabolism and excretion (ADME) studies with respect to our clinical and pre-clinical product candidates.”
page 15
10. In this risk factor, please include the reason you have yet to perform ADME studies and whether
or not you intend to conduct such studies in the future.
Response: In response to the Staff’s
comment, we have expanded the disclosure in this risk factor to include the reason why the Company has not yet performed ADME studies
and that the Company does intend to conduct such studies prior to final submission to the FDA for drug approval. Please see page
15 of Amendment No. 1.
“If our competitors are better
able to develop and market products than any products that we and/or any potential future collaborators may develop . . .,”
page 21
11. Please include in this risk factor the names of the companies that you believe will be your principal
competitors and those products that you believe will compete with yours at such time as yours enter the marketplace.
Response: In response to the Staff’s
comment, we have revised the risk factor to include the name of Anthera Pharmaceuticals, Inc. as a competitor of which the Company
is aware and that it has a PLA2 inhibitor currently in Phase 3 clinical trial. Please see page 21 of Amendment No. 1.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo,
P.C.
Securities and Exchange Commission
August 8, 2012
Page 5
“We depend on third-party suppliers
for key raw materials used in our manufacturing processes…” page 22
12. Please include in this risk factor the names of the third-party suppliers you are dependent upon.
Response: In response to the Staff’s
comment, we have revised the disclosure in this risk factor to include the names of the third-party suppliers that the Company
uses. Please see page 22 of Amendment No. 1.
“Use of third-party manufacturers
may increase the risk that we will not have adequate supplies of our product candidates or products.” page 24
13. You disclose that your present or future manufacturing partners may not be able to comply with
FDA-mandated current Good Manufacturing Practice regulations or other FDA regulatory requirements. To the extent you are aware
that one or more of your current manufacturing partners do not comply with FDA-mandated current Good Manufacturing Practice regulations
or other FDA regulatory requirements, please disclose this fact as well as the names of each manufacturing partner that does not
comply.
Response: All of the Company’s
manufacturing partners are compliant with current Good Manufacturing Practice regulations, and we have revised the disclosure on
page 24 of Amendment No. 1 in response to the Staff’s comment to reflect this fact.
“We rely on third parties to
conduct our clinical trials, and those third parties may not perform satisfactorily…,” page 25
14. Please include in this risk factor the names of the material contract research organizations that
have performed your clinical trials to date.
Response: We have revised the risk
factor at issue to include the name of the material contract research organization that performs the Company’s clinical trials.
Please see page 25 of Amendment No. 1.
“If we do not establish strategic
collaborations, we may have to alter our development plans.” page 25
15. This risk factor is substantially similar to the second one on page 22. Please merge them into
a single risk factor in order to avoid repetition in your disclosure.
Response: In response to the Staff’s
comment, we have merged the two risk factors at issue into a single risk factor. Please see page 22 of Amendment No. 1.
“We will incur increased costs
and demands upon management as a result of complying with the laws and regulations affecting public companies…,” page
33
16. Please estimate the costs you will incur as a result of complying with public company laws and
regulations over the next fiscal year and on an annual basis thereafter.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo,
P.C.
Securities and Exchange Commission
August 8, 2012
Page 6
Response: In response to the Staff’s
comment, we have included disclosure regarding the estimate of costs that the Company will incur as a result of complying with
public company laws and regulations over the next fiscal year and on an annual basis thereafter. Please see page 33 of Amendment
No. 1.
Item 4. Information on the Company
A. History and Development of the Company
April 2012 Private Placement of Senior
Secured Convertible Notes and Warrants, page 38
17. In your “Description of Notes” on page 40 please provide the definition of “material
adverse event” in your Securities Purchase Agreement.
Response: In response to the Staff’s
comment, we have provided the definition of “material adverse effect” (“material adverse event” was a typographical
error). Please see page 40 of Amendment No. 1.
18. In your description of the Registration Rights Agreement on page 40, please disclose the actual
date rather than referring to the “Self Filing Effective Date” and describe the payments you will be required to make
to your investors if this registration statement is not filed and/or declared effective on a timely basis.
Response: We respectfully refer
the Staff to page 38 of Amendment No. 1, where “Self Filing Effective Date” has already been defined. We have, however,
in response to the Staff’s comment, amended the disclosure to describe the payments the Company will have to make to its
investors if this registration statement is not filed and/or declared effective on a timely basis. Please see page 40 of Amendment
No. 1.
B. Business Overview
Product Candidates, page 41
19. Please state here, as well as in your discussion of your clinical pipeline on page 49 and your
Overview on page 68, that the clinical trials your two major product candidates have undergone were performed in Israel and South
Africa, and not in the United States.
Response: In response to the Staff’s
comment, we have revised the disclosures at issue to state that the clinical trials are being conducted in Israel and South Africa.
Please see pages 49 and 68 of Amendment No. 1.
20. Please state here and wherever else applicable in your registration statement whether or not you
believe your clinical trials have complied with the rules for such trials set forth by the FDA. If they have not, please specify
how your clinical trials have differed from those rules.
Response: We have added disclosure
in response to the Staff’s comment regarding the Company’s compliance with rules set forth by the FDA regarding the
conduct of clinical trials. Please see pages 41, 51 and 52 of Amendment No. 1.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo,
P.C.
Securities and Exchange Commission
August 8, 2012
Page 7
Steroids and Currently Available
Alternatives, page 42
21. In your table on page 44, please indicate in the row describing your product candidates that your
studies to date have not advanced beyond Phase 2.
Response: We have revised the table
on page 44 of Amendment No. 1 in response to the Staff’s comment to indicate that the studies are currently in Phase 2 clinical
trials.
Scientific Background to Inflammation
and Our Product Candidates, page 45
22. In this disc