Company: BIVIW
Filing Date: 2025-08-08
Form Type: 424B5
Source: 0001520138-25-000247
Chunk: 35

Company: BIOVIE INC.
Filing Date: 2025-08-08
Form: 424B5
Chunk 35
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 the successful completion of adequate and well-controlled human clinical investigations to establish the safety and efficacy of the
product for its recommended use; and (d) filing by a company and acceptance and approval by the FDA of a NDA for a drug product or a BLA
for a biological product to allow commercial distribution of the drug or biologic. A delay in one or more of the procedural steps outlined
above could be harmful to us in terms of getting our product candidates through clinical testing and to market, which could have a materially
adverse effect on our business.

The FDA, clinical investigators, Data Safety Monitoring
Boards, and IRBs review the ongoing conduct of, and emerging safety information from, clinical trials and may order the temporary or permanent
discontinuation of clinical trials at any time if it believes the product candidate exposes clinical subjects to an unacceptable health
risk. Investigational drugs used in clinical studies must be produced in compliance with cGMP rules pursuant to FDA regulations.

Development, approval, and sales outside the United
States of products that we develop will also be subject to regulatory requirements governing human clinical trials and marketing for drugs
and biological products and devices. The requirements vary widely from country to country, but typically the registration and approval
process takes several years and requires significant resources.

If we experience delays or discontinuations of
our clinical trials by the FDA or comparable authorities in other countries, or if we fail to obtain registration or other approvals of
our products or devices then we could be forced to cease our operations and you will lose all of your investment.

Even if we are successful in developing BIV201
and bezisterim (NE3107), our product candidates, we have limited experience in conducting or supervising clinical trials that must be
performed to obtain data to submit in concert with applications for approval by the FDA. The regulatory process to obtain approval for
drugs for commercial sale involves numerous steps. Drugs are subjected to clinical trials that allow development of case studies to examine
safety, efficacy, and other issues to ensure that sale of drugs meets the requirements set forth by various governmental agencies, including
the FDA. In the event that our protocols do not meet standards set forth by the FDA, or that our data is not sufficient to allow such
trials to validate our drugs in the face of such examination, we might not be able to meet the requirements that allow our drugs to be
approved for sale which could have a materially adverse effect on our business.

We depend upon our management and their