SEC Comment Letter 0000000000-24-004397 to NANOVIRICIDES, INC. (NNVC) (CIK 0001379006) (NNVC)
NANOVIRICIDES, INC. (NNVC) (CIK 0001379006)
Date: April 22, 2024 · CIK: 0001379006 · Accession: 0000000000-24-004397
AI Filing Summary & Sentiment
Reasoning
File numbers found in text: 001-36081
Letter
United States securities and exchange commission logo April 22, 2024 Meeta Vyas Chief Financial Officer NanoViricides, Inc 1 Controls Drive Shelton, CT 06484 Re:NanoViricides, Inc Form 10-K for Fiscal Year Ended June 30, 2023 Response dated April 9, 2024 File No. 001-36081 Dear Meeta Vyas: We have reviewed your April 9, 2024 response to our comment letter and have the following comment. Please respond to this letter within ten business days by providing the requested information or advise us as soon as possible when you will respond. If you do not believe a comment applies to your facts and circumstances, please tell us why in your response. After reviewing your response to this letter, we may have additional comments. 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. Please contact Li Xiao at 202-551-4391 or Daniel Gordon at 202-551-3486 if you have questions regarding comments on the financial statements and related matters. Please contact Tyler Howes at 202-551-3370 or Alan Campbell at 202-551-4224 with any other questions.
FirstName LastNameMeeta Vyas Comapany NameNanoViricides, Inc April 22, 2024 Page 2 FirstName LastName Meeta Vyas NanoViricides, Inc April 22, 2024 Page 2 Sincerely, Division of Corporation Finance Office of Life Sciences
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United States securities and exchange commission logo
April 22, 2024
Meeta Vyas
Chief Financial Officer
NanoViricides, Inc
1 Controls Drive
Shelton, CT 06484
Re:NanoViricides, Inc
Form 10-K for Fiscal Year Ended June 30, 2023
Response dated April 9, 2024
File No. 001-36081
Dear Meeta Vyas:
We have reviewed your April 9, 2024 response to our comment letter and have the
following comment.
Please respond to this letter within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe a
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to this letter, we may have additional comments.
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.
Please contact Li Xiao at 202-551-4391 or Daniel Gordon at 202-551-3486 if you have
questions regarding comments on the financial statements and related matters. Please contact
Tyler Howes at 202-551-3370 or Alan Campbell at 202-551-4224 with any other questions.
FirstName LastNameMeeta Vyas
Comapany NameNanoViricides, Inc
April 22, 2024 Page 2
FirstName LastName
Meeta Vyas
NanoViricides, Inc
April 22, 2024
Page 2
Sincerely,
Division of Corporation Finance
Office of Life Sciences