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SEC Comment Letter for NANOVIRICIDES, INC. (NNVC) (CIK 0001379006) (NNVC) — Dec 12, 2006

NANOVIRICIDES, INC. (NNVC) (CIK 0001379006)
Date: Dec. 12, 2006 · CIK: 0001379006 · Accession: 0000000000-06-060570

AI Filing Summary & Sentiment

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Date
December 11, 2006
Author
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UPLOAD
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NANOVIRICIDES, INC. (NNVC) (CIK 0001379006)

Letter

Mail Stop 6010 December 11, 2006 Eugene Seymour, M.D. Chief Executive Officer NanoViricides, Inc. 135 Wood Street, Suite 205 West Haven, CT 06516

Re: NanoViricides, Inc. Form 10-SB12G Filed on November 14, 2006 File No. 0-52318

Dear Dr. Seymour:

We have reviewed your filing and have the following comments. Where indicated, we think you should revise your documents 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.

Your Website at www.nanoviricides.com

1. 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

Eugene Seymour NanoViricides, Inc. December 11, 2006 Page 2 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.

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 may cases, even cure of many diseases.” (page 6)

• “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.

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 H2N1 (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 will 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 a ppear 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.

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.

Eugene Seymour NanoViricides, Inc. December 11, 2006 Page 3

Form 10-SB12G

General

5. 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.

6. Pursuant to section 12(g)(1) 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.

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.

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) • “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

Eugene Seymour NanoViricides, Inc. December 11, 2006 Page 4 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 technologi es 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 HIV 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.

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) • “Non-H5N1 HPAI strains are expected to become the next pandemic threats on the horizon.” (page 5) • “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) • “While the HIV-1 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) • “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 toll is estimated at upwards of 200,000 per year. (page 12) • “Of the avian influenza viruses that have crossed the species barrier to infect humans, the H5N1 has caused the largest number of detected cases of severe disease and death in humans” (page 13) • “Congress has recently approved an appropriation of $3.8 billion for 2006 to support the development of various countermeasures for a flu pandemic.” (page 14)

Eugene Seymour NanoViricides, Inc. December 11, 2006 Page 5 • “We have identified several diseases as large commercially important drug development targets. These include HIV (estimated yearly sales worldwide, $20-$40 Billion), Hepatitis C (currently over $4 Billion, but expected to become over $40 Billion with the advent of effective drugs). . . .” (page 15)

10. We note your disclosure in the document where you provide the results of some of your preliminary studies. We also note you have provided some disclaimer language indicating that the results of the studies are preliminary and that you will need further testing. Please revise your discussions here and throughout your document as appropriate to describe the tests that you have conducted which have yielded these results and to also include appropriate caveats indicating that the results do not provide enough evidence regarding efficacy or safety to support an application with the FDA, that additional tests will be conducted and that subsequent results often do not corroborate earlier results.

11. In instances where you have stated that the preclinical testing has shown efficacy, please revise to describe the results which have led you to conclude the product candidate is effective. These results should be quantified to the extent possible.

12. With respect to your discussion of preliminary studies you have conducted or were conducted on your behalf by others, please also indicate whether the results of your studies have been subject to any type of statistical analysis and, if so, whether the results were statistically significant. In addition, th e degree of statistical significance or the P value should be disclosed and explained.

Special Note on Forward-Looking Statements, page 3

13. Your references to the Securities Act and the Exchange Act should be deleted. You are not a reporting company and your forward-looking statements do not appear to be protected by the safe harbors contained in those statutes.

Corporate History, page 3

14. Please expand the last paragraph of this section to discuss the following:

• You have no revenue, customer or products, nor will you likely have any in the near future and may never have any; • You are an early development stage company that has barely commenced operation. • Quantify your accumulated deficit, and net and operating losses. • Your auditors have issued a going concern qualification as part of their opinion.

Preliminary Safety Studies In Vivo, page 7

Eugene Seymour NanoViricides, Inc. December 11, 2006 Page 6 15. Please expand your disclosure of the in vivo studies to describe what type of studies these constitute and where completion of these studies will place you in the regulatory approval process, i.e., the FDA process.

16. Please explain the meaning of the term “”pendant polymeric micelles.”

Implications of the Study Results, page 8

17. Please explain what a “proof-of principle” is.

18. Please delete the statement that you can quickly develop a drug against a virus once a suitable virus-binding compound is found.

Subcontract to KARD Scientific, Inc., page 8

19. We note your statement that you do not have any direct collaborative relationships with Beth Israel or Harvard University, except through KARD Scientific. Please explain any indirect relationships with Beth Israel and Harvard. If the only relationship is that you have a collaborative relationship with KARD and they have unrelated arrangements with Beth Israel and Harvard University, then you should delete the references to these parties.

20. Provide a further description of your agreement with KARD Scientific, including what it means to be your primary vendor for animal model study design and performance and payment provisions.

Collaboration with the Health Ministry of the Government of Vietnam, page 9

21. Please describe the material terms of your ag reement with the Health Ministry of the Government of Vietnam, including each pa rty’s obligations, funding arrangements, payment terms, ownership of any discoveries, the existence of royalties, duration and termination provisions and any other terms deemed material. The discussion of payment terms should include any amounts paid or received to date and the aggregate amount of any potential milestone payments.

22. Please file your agreements with the Health Ministry or explain the basis for your belief that they are not required to be filed.

Eugene Seymour NanoViricides, Inc. December 11, 2006 Page 7

Other Collaborations, page 9

23. You indicate that you have made significant effo rts in the past year to obtain valuable collaborations agencies, institutions and commercial enterprises. You further state that as efforts materialize into formal arrangements, you will able to announce them. Please specify what these significant efforts were in the past year. Please also indicate the status of your arrangements with the collaboration agencies, institutions and commercial enterprises with which it appears you may enter formal arrangements.

24. Also, revise to specifically note that the efforts might not materialize into formal agreements.

25. You indicate that you anticipate that much of your work in the tropical and neglected disease areas and in the areas of bio-defense and emergency preparedness aspects will be conducted in collaborations with renowned institutions. Please explain what you mean by “tropical and neglected disease.” Please also explain the basis for your statement that you plan to conduct much of your work in the areas identified with “renowned institutions.” Do you currently have work in progress with such institutions? If you have work in progress with these institutions, please identify them and describe your arrangements. If you do not have work in progress or arrangements, then delete the reference to “renowned institutions.”

26. We note that you a

Show Raw Text
Mail Stop 6010

       December 11, 2006

Eugene Seymour, M.D.
Chief Executive Officer
NanoViricides, Inc.
135 Wood Street, Suite 205
West Haven, CT  06516

Re: NanoViricides, Inc.
 Form 10-SB12G Filed on November 14, 2006
 File No. 0-52318

Dear Dr. Seymour:

 We have reviewed your filing and have the following comments.  Where indicated, we
think you should revise your documents 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.

Your Website at www.nanoviricides.com

1. 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

Eugene Seymour
NanoViricides, Inc.  December 11, 2006 Page 2
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.

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 may cases, even cure of many diseases.” (page 6)

• “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.

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 H2N1 (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 will 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 a ppear 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.

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.

Eugene Seymour
NanoViricides, Inc.  December 11, 2006 Page 3

Form 10-SB12G

General

5. 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.

6. Pursuant to section 12(g)(1) 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.

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.

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)
• “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

Eugene Seymour
NanoViricides, Inc.  December 11, 2006 Page 4
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 technologi es 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 HIV 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.

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)
• “Non-H5N1 HPAI strains are expected to become the next pandemic threats on the horizon.” (page 5)
• “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)
• “While the HIV-1 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)
• “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 toll is estimated at upwards of 200,000 per year. (page 12)
• “Of the avian influenza viruses that have crossed the species barrier to infect humans, the H5N1 has caused the largest number of detected cases of severe disease and death in humans” (page 13)
• “Congress has recently approved an appropriation of $3.8 billion for 2006 to support the development of various countermeasures for a flu pandemic.”  (page 14)

Eugene Seymour
NanoViricides, Inc.  December 11, 2006 Page 5
• “We have identified several diseases as large commercially important drug development targets.  These include HIV (estimated yearly sales worldwide, $20-$40 Billion), Hepatitis C (currently over $4 Billion, but expected to become over $40 Billion with the advent of effective drugs). . . .” (page 15)

10. We note your disclosure in the document where you provide the results of some of your preliminary studies. We also note you have provided some disclaimer language indicating that the results of the studies are preliminary and that you will need further testing. Please revise your discussions here and throughout your document as appropriate to describe the tests that you have conducted which have yielded these results and to also include appropriate caveats indicating that the results do not provide enough evidence regarding efficacy or safety to support an application with the FDA, that additional tests will be conducted and that subsequent results often do not corroborate earlier results.

11. In instances where you have stated that the preclinical testing has shown efficacy, please revise to describe the results which have led you to conclude the product candidate is effective.  These results should be quantified to the extent possible.

12. With respect to your discussion of preliminary studies you have conducted or were conducted on your behalf by others, please also indicate whether the results of your studies have been subject to any type of statistical analysis and, if so, whether the results were statistically significant.  In addition, th e degree of statistical significance or the P
value should be disclosed and explained.

Special Note on Forward-Looking Statements, page 3

13. Your references to the Securities Act and the Exchange Act should be deleted. You are not a reporting company and your forward-looking statements do not appear to be protected by the safe harbors contained in those statutes.

Corporate History, page 3

14. Please expand the last paragraph of this section to discuss the following:

• You have no revenue, customer or products, nor will you likely have any in the near future and may never have any;
• You are an early development stage company that has barely commenced operation.
• Quantify your accumulated deficit, and net and operating losses.
• Your auditors have issued a going concern qualification as part of their opinion.

Preliminary Safety Studies In Vivo, page 7

Eugene Seymour
NanoViricides, Inc.  December 11, 2006 Page 6
15. Please expand your disclosure of the in vivo studies to describe what type of studies these constitute and where completion of these studies will place you in the regulatory approval process, i.e., the FDA process.

16. Please explain the meaning of the term “”pendant polymeric micelles.”

Implications of the Study Results, page 8

17. Please explain what a “proof-of principle” is.

18. Please delete the statement that you can quickly develop a drug against a virus once a suitable virus-binding compound is found.

Subcontract to KARD Scientific, Inc., page 8

19. We note your statement that you do not have any direct collaborative relationships with Beth Israel or Harvard University, except through KARD Scientific.  Please explain any indirect relationships with Beth Israel and Harvard.  If the only relationship is that you
have a collaborative relationship with KARD and they have unrelated arrangements with Beth Israel and Harvard University, then you should delete the references to these parties.

20. Provide a further description of your agreement with KARD Scientific, including what it means to be your primary vendor for animal model study design and performance and payment provisions.

Collaboration with the Health Ministry of the Government of Vietnam, page 9

21. Please describe the material terms of your ag reement with the Health Ministry of the
Government of Vietnam, including each pa rty’s obligations, funding arrangements,
payment terms, ownership of any discoveries, the existence of royalties, duration and termination provisions and any other terms deemed material.  The discussion of payment terms should include any amounts paid or received to date and the aggregate amount of any potential milestone payments.

22. Please file your agreements with the Health Ministry or explain the basis for your belief that they are not required to be filed.

Eugene Seymour
NanoViricides, Inc.  December 11, 2006 Page 7

Other Collaborations, page 9

23. You indicate that you have made significant effo rts in the past year to obtain valuable
collaborations agencies, institutions and commercial enterprises. You further state that as efforts materialize into formal arrangements, you will able to announce them. Please specify what these significant efforts were in the past year. Please also indicate the status
of your arrangements with the collaboration agencies, institutions and commercial enterprises with which it appears you may enter formal arrangements.

24. Also, revise to specifically note that the efforts might not materialize into formal agreements.

25. You indicate that you anticipate that much of your work in the tropical and neglected disease areas and in the areas of bio-defense and emergency preparedness aspects will be conducted in collaborations with renowned institutions. Please explain what you mean by “tropical and neglected disease.”  Please also explain the basis for your statement that you plan to conduct much of your work in the areas identified with “renowned institutions.” Do you currently have work in progress with such institutions?  If you have work in progress with these institutions, please identify them and describe your arrangements.  If you do not have work in progress or arrangements, then delete the reference to “renowned institutions.”

26. We note that you a