Company: BIVIW
Filing Date: 2025-07-11
Form Type: S-1/A
Source: 0001520138-25-000205
Chunk: 37

Company: BIOVIE INC.
Filing Date: 2025-07-11
Form: S-1/A
Chunk 37
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 applications, suspension or termination of clinical investigations,
revocation of approvals previously granted, warning letters, fines, criminal prosecution, recalls or seizures of products, injunctions
against shipping drugs and total or partial suspension of production and/or refusal to allow a company to enter into governmental supply
contracts.

The process of obtaining FDA approval is costly
and time consuming. Current FDA requirements for a new human drug or biological product to be marketed in the United States include, among
other things: (a) the successful conclusion of pre-clinical laboratory and animal tests, if appropriate, to gain preliminary information
on the product’s safety; (b) filing with the FDA of an IND application to conduct human clinical trials for drugs or biologics;
(c) 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