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SEC Company Response from NANOVIRICIDES, INC. (NNVC) (CIK 0001379006) (NNVC) — Jan 17, 2007

NANOVIRICIDES, INC. (NNVC) (CIK 0001379006)
Date: Jan. 17, 2007 · CIK: 0001379006 · Accession: 0001140361-07-001307

AI Filing Summary & Sentiment

Sentiment
Urgency
Document Type
Confidence
SEC Posture
Company Posture

Summary

Reasoning

Referenced dates: December 11, 2006

Date
Jan. 17, 2007
Author
Director
Form
CORRESP
Company
NANOVIRICIDES, INC. (NNVC) (CIK 0001379006)

Letter

Via EDGAR and OVERNIGHT DELIVERY Securities and Exchange Commission Division of Corporate Finance Re: NanoViricides, Inc. Form 10-SB12G Filed on November 14, 2006 File No. 0-52318

Dear Mr. Riedler:

Please be advised that this firm is special securities counsel to NanoViricides, Inc., the above-referenced issuer (the “Issuer”). This letter is in response to the comments of the Staff of the U.S. Securities and Exchange Commission (the “Commission”) with respect to the above-referenced filing provided in your letter dated December 11, 2006 (the “Comment Letter”). In response to these comments, the Issuer has caused to be filed Amendment No. 1 to the Form 10-SB, a redlined version of which is enclosed with the original of this letter. The purpose of this correspondence is to illustrate these changes to the Commission and provide explanation, where necessary. Our responses follow the text of each Staff comment reproduced consecutively for your convenience.

Comment No 1:

Your Website at www.nanoviricides.com

We make reference to the homepage of your webpage where you state that you believe that “[i]t is possible that some HIV patients may be ‘cured’ by drugs developed at NanoViricides Inc.” You also state that you hope to “spearhead” the efforts to making advancements in curing many viral diseases. In contrast we note the statement on page 6 of your Form 10 that you do not claim to be creating a cure of influenza, HIV or any other viral disease. Please explain the inconsistencies.

These statements have been deleted from both the Registration Statement and the Issuer’s website.

Comment No 2:

Additionally, given the current stages of your potential product candidates, it is inappropriate for you to suggest that any persons may be cured by using your products. For example:

•“Our long term research efforts are aimed at augmenting the nanoviricides currently in development with additional agents that together may lead to either total long term control of or, in many cases, even cure of many diseases.” (page 6)

LEVY & BOONSHOFT, P.C.

Securities and Exchange Commission

Page 2 of

•The Company does not expect HiviCide-I and HiviCide-II to cure HIV/AIDS in most patients.” (page 12)

•“It is possible that since the cells that carry the virus genome with their genetic material usually die in a normal cycle, known as apoptosis; an eventual cure in some patients may be possible with our HiviCide drugs.” (page 12)

Please delete these statements.

The Registration Statement has been revised to delete these statements accordingly.

Comment No 3:

We make reference to your NanoBiotech News (Volume 4, No. 10) which was issued on March 8, 2006. In that newsletter, there is a statement indicating that your Chief Regulatory Officer, Krishna Menon proposes that preliminary data conducted in December 2005 related to the H2Nl (common influenza) strain “is sufficient to file an investigational new drug application with the U.S. Food and Drug Administration.” Your President, Anil Diwan is then quoted as saying that “I don’t have the actual data yet. . . but we’re seeing magnitudes of efficacy improvements over the ligand.” Please provide us with more details on the results of these studies, including whether the results of these studies were completely analyzed and whether you intend to submit an IND in the near future with the FDA or if you win need to conduct additional tests prior to submitting an IND. Please note that we also note the disclosure you have in your registration statement under the section entitled “Background: Preclinical Safety and Efficacy Studies’; on page 7 and it does not appear you provide any disclosure regarding the filing of an IND in the near future. Please explain accordingly. We may have additional questions after reviewing your response.

Please note that the Issuer neither wrote nor had the opportunity to edit the NanoBiotech News. However, all references to the article have been removed from the Issuer’s updated website. The section of the Registration Statement “Background: Preclinical Safety and Efficacy Studies” was revised to include the Issuer’s intentions with reference to filing an IND as follows:

The discussions in this section and throughout this Form 10-SB registration statement describe the tests that have been conducted which have yielded these results. These results do not provide enough evidence regarding efficacy or safety to support an application with the FDA. Additional tests will need to be conducted. It must be noted that subsequent results often do not corroborate earlier results.

Comment No 4:

Also in the newsletter under the caption “Potential pharma partners line up,” there is language indicating that “[i]n conjunction with an expected IND filing, you are also positioned to begin licensing FluCide to major pharmaceutical partners and further that potential licensees have begun making inquiries. Please tell us if you have or intend to being marketing your FluCide drug candidate in the near future as we understand based on the disclosure in your Form 10-SB that this drug candidate is still in the early development phase. We may have additional questions after reviewing your response.

The Issuer has deleted all references to the article in its new website.

LEVY & BOONSHOFT, P.C.

Securities and Exchange Commission

Page 3 of

Comment No 5:

General

Where comments on one section also relate to disclosure in another section, please make parallel changes to all affected disclosures. This will eliminate the need for us to repeat similar comments.

The Registration Statement has been revised accordingly.

Comment No 6:

Pursuant to section 12(g)(l) of the Exchange Act, your registration statement will become effective by operation of law on January 16, 2007 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 January 16, 2007 to prevent it from becoming effective and refiling it at such time as you are able to respond to any remaining issues or comments.

The Issuer believes its first amendment to the Registration Statement has sufficiently responded to the Commission’s comments.

Comment No 7:

Please revise your filing to include updated financial statements and related disclosures through September 30, 2006 as required by Item 310(g) of Regulation S-B.

The Registration Statement has been revised to provide the updated financial statement material.

Comment No 8:

As a general matter, it is inappropriate to speak about the merits of the company without qualifying your statements in a manner that make clear to the reader that the company is in the developmental stage and has commenced minimal operations. Unless you have demonstrable proof of statement concerning what the company or its product candidates can do or are capable of, you should not make such statements. You may state your objectives and/or goals but you cannot state your beliefs or expectations unless you have a supportable basis for such beliefs or expectations. For example, we note the following, which we note is not meant to be exhaustive, but rather is provided for illustrative purposes.

•“The Company believes that our drugs may become the major weapons in the fight against certain viral diseases, possibly even after the other therapies have failed.” (page 6)

•“The Company also plans to seek regulatory approvals in several international markets. . . and anticipates partnering with medium and large pharmaceutical companies at various opportunities in order to advance the various drugs into commercialization. (page 6)

•“It appears very likely that using the nanoviricides technology, the efficacy of such a drug may be enhanced by orders of magnitude.” (page 8)

•“We anticipate that much of our work in the tropical and neglected diseases as well as in the areas of interest to bio-defense and emergency preparedness aspects will be conducted in collaborations with renowned institutions” (page 9)

LEVY & BOONSHOFT, P.C.

Securities and Exchange Commission

Page 4 of

•We believe that it is possible, in war-like scenario, to develop a response to the biological weapons attack in a manner of days or weeks. Similarly we believe that when a new virus outbreak occurs. . . this building block technology may enable us to develop a new drug to fight the new threat in a minimal amount of time.” (page 10)

“The Company believes that it can help contain epidemics before they can occur in what the company terms the ‘War-like’ scenario of response to a bio-threat, whether due to bio-terrorism or natural events.” (page 10)

“The Company believes that it will be able to rapidly create new drugs against escape mutants, should they arise, due to our building block approach.” (page 12)

•“We believe that we have developed technologies that may significantly alter the field of medicine in many ways.” (page 15)

•“Our first two HIV drugs. . . together are expected to be capable of attacking and neutralizing most of the existing HN strains, clades (or subtypes), and types. The Company believes that our HiviCide drugs will enable a long-term nearly virus-free lifestyle for most HIV/AIDS patients, beyond what is feasible today with HAART therapy.” (page 17).

•“[T]o the best of our knowledge it is possible that we have the world’s most efficacious drug to treat these viruses [human influenza and bird flu]” (page 43)

Given the preliminary nature of the development of your product candidates, these statements are inappropriate and should be deleted from your document.

These statements have been deleted from the Registration Statement.

Comment No 9:

Please provide us with third party documentation supporting the following statements you make in this section:

“We believe NanoViricides is the first company to bring this proven feature to the anti -viral therapy platform:’ (page 5)

Nanomedicines against anticancer are an established goal of the NCI/NIH nanotechnology initiative.

“Non-H5N1 HP AI strains are expected to become the next pandemic threats on the horizon.” (page 5)

NIH has funded Sanofi to develop a vaccine against H7N1. This is a non H5N1 highly pathogenic influenza A strain.

http://www.sanofipasteur.com/sanofi-pasteur/ImageServlet?siteCode=AVPI_US&imageCode=17693&codeSite=AVPI_US.

“There is now acceptance in the industry, the scientific community and the public health community that injectable drugs should be developed and deployed when they provide high efficacies,” (page 8)

“BioCryst life threatening influenza injection fast tracked”

18th January 2006

By Staff Writer

The FDA has granted fast track designation to BioCryst Pharmaceuticals peramivir injection for the treatment of influenza infections, including highly virulent, life-threatening strains of influenza such as avian flu.

LEVY & BOONSHOFT, P.C.

Securities and Exchange Commission

Page 5 of

Peramivir is an influenza neuraminidase inhibitor that, in preclinical studies, has shown potent, broad spectrum activity against multiple strains of flu, including the H5N1 virus.

On December 22, 2005, BioCryst announced that the FDA had given the company approval to begin human clinical trials using injectable peramivir.

In correspondence with BioCryst, the FDA said that it agrees that the use of peramivir in the proposed indication meets the criterion of treating a serious life-threatening condition. Based on this conclusion, the FDA designated peramivir injection for influenza infection as a fast track product, meaning that the drug will be the subject of a faster regulatory process.

"The FDA's decision supports our belief in the potential of peramivir as an effective therapy for the treatment of influenza, including highly virulent, life-threatening strains like those associated with avian influenza," said Dr Charles Bugg, chairman and CEO of BioCryst.

“While the HIV-l type is prevalent in North America, Europe, and a majority of the World, a distinct HIV type called HIV-2 with a marked prevalence in West Africa, has recently been spreading worldwide.” (page 12)

Please see the chapter on Human Retroviruses. Longo, DL and Fauci, AS “The Human Retroviruses” in Harrison’s Principles of Internal Medicine, 16th ed. McGraw Hill. pp. 1071- 1076. Also, AS Fauci and H Clifford-Lane, “”HIV Disease: AIDS and Related Disorders”, pp. 1076-1139, ibid.

“According to the US Centers for Disease Control and Prevention (‘CDC’), an estimated 5% to 20% of the American population suffers from influenza annually, more than 200,000 people are hospitalized from flu complications, and approximately 36,000 people die from the flu in the US. The worldwide death

Show Raw Text
CORRESP
1
filename1.htm

      NanoViricides Corresp 01-16-2007

      LEVY
        & BOONSHOFT, P.C.

      ATTORNEYS
        AT LAW

      477
        MADISON AVENUE

      NEW
        YORK,
        NEW YORK 10022

      (212)
        751-1414

      FACSIMILE:
        (212) 751-6943

                January
                  16, 2007

      Via
        EDGAR and OVERNIGHT DELIVERY

      Mr.
        Jeffrey Riedler

      Assistant
        Director

      Securities
        and Exchange Commission

      Division
        of Corporate Finance

      100
        F
        Street, N.E.

      Mail
        Stop
        6010

      Washington
        DC 20549

                Re:

                NanoViricides,
                  Inc.

      Form
        10-SB12G Filed on November 14, 2006

      File
        No. 0-52318

      Dear
        Mr.
        Riedler:

      Please
        be
        advised that this firm is special securities counsel to NanoViricides, Inc.,
        the
        above-referenced issuer (the “Issuer”). This letter is in response to the
        comments of the Staff of the U.S. Securities and Exchange Commission (the
        “Commission”) with respect to the above-referenced filing provided in your
        letter dated December 11, 2006 (the “Comment Letter”). In response to these
        comments, the Issuer has caused to be filed Amendment No. 1 to the Form 10-SB,
        a
        redlined version of which is enclosed with the original of this letter. The
        purpose of this correspondence is to illustrate these changes to the Commission
        and provide explanation, where necessary. Our responses follow the text of
        each
        Staff comment reproduced consecutively for your convenience.

      Comment
        No 1:

      Your
        Website at www.nanoviricides.com

      We
        make reference to the homepage of your webpage where you state that you believe
        that “[i]t is possible that some HIV patients may be ‘cured’ by drugs developed
        at NanoViricides Inc.” You also state that you hope to “spearhead” the efforts
        to making advancements in curing many viral diseases. In contrast we note
        the
        statement on page 6 of your Form 10 that you do not claim to be creating
        a cure
        of influenza, HIV or any other viral disease. Please explain the
        inconsistencies.

      These
        statements have been deleted from both the Registration Statement and the
        Issuer’s website.

      Comment
        No 2:

      Additionally,
        given the current stages of your potential product candidates, it is
        inappropriate for you to suggest that any persons may be cured by using your
        products. For example:

      •“Our
        long term research efforts are aimed at augmenting the nanoviricides currently
        in development with additional agents that together may lead to either total
        long term control of or, in many cases, even cure of many diseases.” (page 6)

      LEVY
        & BOONSHOFT, P.C.

      Securities
        and Exchange Commission

      Page
        2 of
        27

      •The
        Company does not expect HiviCide-I and HiviCide-II to cure HIV/AIDS in most
        patients.” (page 12)

      •“It
        is possible that since the cells that carry the virus genome with their genetic
        material usually die in a normal cycle, known as apoptosis; an eventual cure
        in
        some patients may be possible with our HiviCide drugs.” (page
        12)

      Please
        delete these statements.

      The
        Registration Statement has been revised to delete these statements
        accordingly.

      Comment
        No 3:

      We
        make reference to your NanoBiotech News (Volume 4, No. 10) which was issued
        on
        March 8, 2006. In that newsletter, there is a statement indicating that your
        Chief Regulatory Officer, Krishna Menon proposes that preliminary data conducted
        in December 2005 related to the H2Nl (common influenza) strain “is sufficient to
        file an investigational new drug application with the U.S. Food and Drug
        Administration.” Your President, Anil Diwan is then quoted as saying that “I
        don’t have the actual data yet. . . but we’re seeing magnitudes of efficacy
        improvements over the ligand.” Please provide us with more details on the
        results of these studies, including whether the results of these studies
        were
        completely analyzed and whether you intend to submit an IND in the near future
        with the FDA or if you win need to conduct additional tests prior to submitting
        an IND. Please note that we also note the disclosure you have in your
        registration statement under the section entitled “Background: Preclinical
        Safety and Efficacy Studies’; on page 7 and it does not appear you provide any
        disclosure regarding the filing of an IND in the near future. Please explain
        accordingly. We may have additional questions after reviewing your
        response.

      Please
        note that the Issuer neither wrote nor had the opportunity to edit the
        NanoBiotech News. However, all references to the article have been removed
        from
        the Issuer’s updated website. The section of the Registration Statement
“Background: Preclinical Safety and Efficacy Studies” was revised to include the
        Issuer’s intentions with reference to filing an IND as follows:

      The
        discussions in this section and throughout this Form 10-SB registration
        statement describe the tests that have been conducted which have yielded
        these
        results. These results do not provide enough evidence regarding efficacy
        or
        safety to support an application with the FDA. Additional tests will need
        to be
        conducted. It must be noted that subsequent results often do not corroborate
        earlier results.

      Comment
        No 4:

      Also
        in the newsletter under the caption “Potential pharma partners line up,” there
        is language indicating that “[i]n conjunction with an expected IND filing, you
        are also positioned to begin licensing FluCide to major pharmaceutical partners
        and further that potential licensees have begun making inquiries. Please
        tell us
        if you have or intend to being marketing your FluCide drug candidate in the
        near
        future as we understand based on the disclosure in your Form 10-SB that this
        drug candidate is still in the early development phase. We may have additional
        questions after reviewing your response.

      The
        Issuer has deleted all references to the article in its new website.

      LEVY
        & BOONSHOFT, P.C.

      Securities
        and Exchange Commission

      Page
        3 of
        27

      Comment
        No 5:

      General

      Where
        comments on one section also relate to disclosure in another section, please
        make parallel changes to all affected disclosures. This will eliminate the
        need
        for us to repeat similar comments.

      The
        Registration Statement has been revised accordingly.

      Comment
        No 6:

      Pursuant
        to section 12(g)(l) of the Exchange Act, your registration statement will
        become
        effective by operation of law on January 16, 2007 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 January 16, 2007 to prevent it from becoming effective and refiling
        it
        at such time as you are able to respond to any remaining issues or
        comments.

      The
        Issuer believes its first amendment to the Registration Statement has
        sufficiently responded to the Commission’s comments.

      Comment
        No 7:

      Please
        revise your filing to include updated financial statements and related
        disclosures through September 30, 2006 as required by Item 310(g) of Regulation
        S-B.

      The
        Registration Statement has been revised to provide the updated financial
        statement material.

      Comment
        No 8:

      As
        a
        general matter, it is inappropriate to speak about the merits of the company
        without qualifying your statements in a manner that make clear to the reader
        that the company is in the developmental stage and has commenced minimal
        operations. Unless you have demonstrable proof of statement concerning what
        the
        company or its product candidates can do or are capable of, you should not
        make
        such statements. You may state your objectives and/or goals but you cannot
        state
        your beliefs or expectations unless you have a supportable basis for such
        beliefs or expectations. For example, we note the following, which we note
        is
        not meant to be exhaustive, but rather is provided for illustrative
        purposes.

      •“The
        Company believes that our drugs may become the major weapons in the fight
        against certain viral diseases, possibly even after the other therapies have
        failed.” (page 6)

      •“The
        Company also plans to seek regulatory approvals in several international
        markets. . . and anticipates partnering with medium and large pharmaceutical
        companies at various opportunities in order to advance the various drugs
        into
        commercialization. (page 6)

      •“It
        appears very likely that using the nanoviricides technology, the efficacy
        of
        such a drug may be enhanced by orders of magnitude.” (page 8)

      •“We
        anticipate that much of our work in the tropical and neglected diseases as
        well
        as in the areas of interest to bio-defense and emergency preparedness aspects
        will be conducted in collaborations with renowned institutions” (page
        9)

      LEVY
        & BOONSHOFT, P.C.

      Securities
        and Exchange Commission

      Page
        4 of
        27

      •We
        believe that it is possible, in war-like scenario, to develop a response
        to the
        biological weapons attack in a manner of days or weeks. Similarly we believe
        that when a new virus outbreak occurs. . . this building block technology
        may
        enable us to develop a new drug to fight the new threat in a minimal amount
        of
        time.” (page 10)

      “The
        Company believes that it can help contain epidemics before they can occur
        in
        what the company terms the ‘War-like’ scenario of response to a bio-threat,
        whether due to bio-terrorism or natural events.” (page 10)

      “The
        Company believes that it will be able to rapidly create new drugs against
        escape
        mutants, should they arise, due to our building block approach.” (page
        12)

      •“We
        believe that we have developed technologies that may significantly alter
        the
        field of medicine in many ways.” (page 15)

      •“Our
        first two HIV drugs. . . together are expected to be capable of attacking
        and
        neutralizing most of the existing HN strains, clades (or subtypes), and types.
        The Company believes that our HiviCide drugs will enable a long-term nearly
        virus-free lifestyle for most HIV/AIDS patients, beyond what is feasible
        today
        with HAART therapy.” (page 17).

      •“[T]o
        the best of our knowledge it is possible that we have the world’s most
        efficacious drug to treat these viruses [human influenza and bird flu]” (page
        43)

      Given
        the preliminary nature of the development of your product candidates, these
        statements are inappropriate and should be deleted from your
        document.

      These
        statements have been deleted from the Registration Statement.

      Comment
        No 9:

      Please
        provide us with third party documentation supporting the following statements
        you make in this section:

      “We
        believe NanoViricides is the first company to bring this proven feature to
        the
        anti -viral therapy platform:’ (page 5)

      Nanomedicines
        against anticancer are an established goal of the NCI/NIH nanotechnology
        initiative.

      “Non-H5N1
        HP AI strains are expected to become the next pandemic threats on the
horizon.”
        (page 5)

      NIH
        has
        funded Sanofi to develop a vaccine against H7N1. This is a non H5N1 highly
        pathogenic influenza A strain.

      http://www.sanofipasteur.com/sanofi-pasteur/ImageServlet?siteCode=AVPI_US&imageCode=17693&codeSite=AVPI_US.

      “There
        is now acceptance in the industry, the scientific community and the public
        health community that injectable drugs should be developed and deployed when
        they provide high efficacies,” (page 8)

      “BioCryst
        life threatening influenza injection fast tracked”

      18th
        January 2006

      By
        Staff
        Writer

      The
        FDA
        has granted fast track designation to BioCryst Pharmaceuticals peramivir
        injection for the treatment of influenza infections, including highly virulent,
        life-threatening strains of influenza such as avian flu.

      LEVY
        & BOONSHOFT, P.C.

      Securities
        and Exchange Commission

      Page
        5 of
        27

      Peramivir
        is an influenza neuraminidase inhibitor that, in preclinical studies, has
        shown
        potent, broad spectrum activity against multiple strains of flu, including
        the
        H5N1 virus.

      On
        December 22, 2005, BioCryst announced that the FDA had given the company
        approval to begin human clinical trials using injectable peramivir.

      In
        correspondence with BioCryst, the FDA said that it agrees that the use of
        peramivir in the proposed indication meets the criterion of treating a serious
        life-threatening condition. Based on this conclusion, the FDA designated
        peramivir injection for influenza infection as a fast track product, meaning
        that the drug will be the subject of a faster regulatory process.

      "The
        FDA's decision supports our belief in the potential of peramivir as an effective
        therapy for the treatment of influenza, including highly virulent,
        life-threatening strains like those associated with avian influenza," said
        Dr
        Charles Bugg, chairman and CEO of BioCryst.

      “While
        the HIV-l type is prevalent in North America, Europe, and a majority of the
        World, a distinct HIV type called HIV-2 with a marked prevalence in West
        Africa,
        has recently been spreading worldwide.” (page 12)

      Please
        see the chapter on Human Retroviruses. Longo, DL and Fauci, AS “The Human
        Retroviruses” in Harrison’s Principles of Internal Medicine, 16th
        ed.
        McGraw Hill. pp. 1071- 1076. Also, AS Fauci and H Clifford-Lane, “”HIV Disease:
        AIDS and Related Disorders”, pp. 1076-1139, ibid.

      “According
        to the US Centers for Disease Control and Prevention (‘CDC’), an estimated 5% to
        20% of the American population suffers from influenza annually, more than
        200,000 people are hospitalized from flu complications, and approximately
        36,000
        people die from the flu in the US. The worldwide death