Company: BIVIW
Filing Date: 2025-07-22
Form Type: S-1/A
Source: 0001520138-25-000216
Chunk: 32

Company: BIOVIE INC.
Filing Date: 2025-07-22
Form: S-1/A
Chunk 32
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 for our product
candidates may be affected by a variety of factors, including technological difficulties, proprietary technology of others, and changes
in government regulation, many of which will not be within our control. In June 2021, FDA approved the drug aducanumab for treatment of
Alzheimer’s despite a strong recommendation against approval from an FDA advisory committee. That FDA approval has generated significant
medical and political controversy, including a Congressional investigation, announced on June 25, 2021, into the basis for FDA’s
approval decision. That investigation, other potential investigations, and negative publicity of FDA’s approval decision could adversely
impact the agency’s oversight of our clinical development program, how the agency may view and act upon any NDA we may file for
bezisterim (NE3107), and the commercial viability of bezisterim (NE3107) if it were to be approved and marketed.

Any delay or further delay in the development,
introduction or marketing of our product candidates could result either in such drugs being marketed at a time when their cost and performance
characteristics would not be competitive in the marketplace or in the shortening of their commercial lives. In light of the long-term
nature of our projects and other risk factors described elsewhere in this document, we may not be able to successfully complete the development
or marketing of any drugs, which could cause us to cease operations.

From time to time, the FDA may have feedback on
our clinical trial designs, including for example certain of our endpoints and outcome measures. As a result, we may consider revisions
to our protocols which may delay progress in implementing our trials. We may fail to successfully develop and commercialize our product
candidate(s) if it is found to be unsafe or ineffective in clinical trials; does not receive necessary approval from the FDA or foreign
regulatory agencies; fails to conform to a changing standard of care for the disease it seeks to treat; or is less effective or more expensive
than current or alternative treatment methods.

Drug development failure can occur at any stage
of clinical trials and as a result of many factors, there can be no assurance that we or our collaborators will reach our anticipated
clinical targets. Even if the trials are successfully completed, clinical data are often susceptible to varying interpretations and analyses,
and we cannot guarantee that the FDA or comparable foreign regulatory authorities will interpret the results as we do, and more trials
could be required before we submit our product candidates for approval. We cannot guarantee that the FDA or comparable foreign