Correspondence 0001104659-24-058925 from NANOVIRICIDES, INC. (NNVC) (CIK 0001379006) (NNVC)
NANOVIRICIDES, INC. (NNVC) (CIK 0001379006)
Date: May 8, 2024 · CIK: 0001379006 · Accession: 0001104659-24-058925
AI Filing Summary & Sentiment
File numbers found in text: 001-36081
Referenced dates: April 22, 2024
Letter
Re: NanoViricides, Inc.
“Nanotechnology-Enabled Targeted Viricides”
A Publicly Traded Issuer, “NNVC”
www.nanoviricides.com
May 8, 2024
Division of Corporation Finance, Office of Life Sciences
United States Securities and Exchange Commission
Washington, D.C. 20549
Form 10-K for Fiscal Year Ended June 30, 2023 Filed October 13, 2023
Response dated April 9, 2024
File No. 001-36081
Ladies and Gentlemen:
Please be advised that the undersigned is the duly-appointed Chief Financial Officer of NanoViricides, Inc., the above-referenced issuer (the “Issuer”). This letter is in response to the comments of the staff (“Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) with respect to the Issuer’s Annual Report on Form 10-K, filed on October 13, 2023 (the “Form 10-K”) and the Issuer’s response dated April 9, 2024 (the “Response”), provided in your letter dated April 22, 2024 (the “Comment Letter”).
The purpose of this correspondence is to provide a response to the Comment Letter and provide explanation, where necessary of the Form 10-K filed on October 13, 2023. Our response follows the text of the Comment Letter, which we have reproduced below for your convenience.
Form 10-K for Fiscal Year Ended June 30, 2023
Item 1: Business
The NanoViricide Platform Technology in Brief, page 5
1. We note your response to prior comment 1 and reissue. Statements that conclude your clinical trials demonstrated the “safety” or “efficacy” of your product candidates are improper without regulatory approval, as conclusions related to safety and efficacy are within the sole authority of the FDA and comparable foreign regulators. In future filings, please discuss the objective results of your pre-clinical and clinical trials without concluding that such results demonstrate that your product candidates are safe or effective.
Page 1 of 2
Controls Drive, Shelton, CT 06484. Email: info@nanoviricides.com
“Nanotechnology-Enabled Targeted Viricides”
A Publicly Traded Issuer, “NNVC”
www.nanoviricides.com
The Issuer respectfully acknowledges the Staff’s comment and will revise future filings to discuss the objective results of our pre-clinical and clinical trials without concluding that such results demonstrate that our product candidates are safe or effective unless so evaluated by applicable regulatory authority.
If you should have any questions about this letter or require any further information, please do not hesitate to contact the undersigned or the Issuer’s counsel, Peter Campitiello, Esq. at (732) 867-9741.
Sincerely,
/s/ Meeta Vyas, CFO
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filename1.htm
“Nanotechnology-Enabled
Targeted Viricides”
A Publicly Traded Issuer,
“NNVC”
www.nanoviricides.com
May 8, 2024
Division of Corporation Finance, Office
of Life Sciences
United States Securities and Exchange
Commission
Washington, D.C. 20549
Re:
NanoViricides, Inc.
Form 10-K for Fiscal Year Ended June 30, 2023 Filed October 13, 2023
Response
dated April 9, 2024
File No. 001-36081
Ladies and Gentlemen:
Please
be advised that the undersigned is the duly-appointed Chief Financial Officer of NanoViricides, Inc., the above-referenced issuer (the
“Issuer”). This letter is in response to the comments of the staff (“Staff”) of the U.S. Securities and Exchange
Commission (the “Commission”) with respect to the Issuer’s Annual Report on Form 10-K, filed on October 13, 2023 (the
“Form 10-K”) and the Issuer’s response dated April 9, 2024 (the “Response”), provided in your letter dated
April 22, 2024 (the “Comment Letter”).
The
purpose of this correspondence is to provide a response to the Comment Letter and provide explanation, where necessary of the Form 10-K
filed on October 13, 2023. Our response follows the text of the Comment Letter, which we have reproduced below for your convenience.
Form 10-K for Fiscal
Year Ended June 30, 2023
Item 1: Business
The NanoViricide
Platform Technology in Brief, page 5
1.
We note your response to prior comment 1 and reissue. Statements that conclude your clinical trials
demonstrated the “safety” or “efficacy” of your product candidates are improper without regulatory approval,
as conclusions related to safety and efficacy are within the sole authority of the FDA and comparable foreign regulators. In future filings,
please discuss the objective results of your pre-clinical and clinical trials without concluding that such results demonstrate that your
product candidates are safe or effective.
Page 1 of 2
1
Controls Drive, Shelton, CT 06484. Email: info@nanoviricides.com
“Nanotechnology-Enabled
Targeted Viricides”
A Publicly Traded Issuer,
“NNVC”
www.nanoviricides.com
The
Issuer respectfully acknowledges the Staff’s comment and will revise future filings to discuss the objective results of our pre-clinical
and clinical trials without concluding that such results demonstrate that our product candidates are safe or effective unless so evaluated
by applicable regulatory authority.
If
you should have any questions about this letter or require any further information, please do not hesitate to contact the undersigned
or the Issuer’s counsel, Peter Campitiello, Esq. at (732) 867-9741.
Sincerely,
/s/ Meeta Vyas, CFO
Meeta Vyas, CFO
Page
2 of 2
1
Controls Drive, Shelton, CT 06484. Email: info@nanoviricides.com