Company: BIVIW
Filing Date: 2025-07-22
Form Type: S-1/A
Source: 0001520138-25-000216
Chunk: 92

Company: BIOVIE INC.
Filing Date: 2025-07-22
Form: S-1/A
Chunk 92
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 of the approval process.

Progress reports detailing the results of the
clinical trials must be submitted at least annually to the FDA and written IND safety reports must be submitted to the FDA by the investigators
for serious and unexpected adverse events or any finding from tests in laboratory animals that suggests a significant risk for human subjects.
Phase 1, Phase 2 and Phase 3 clinical trials may not be completed successfully within any specified period, if at all. The FDA or the
sponsor or its data safety monitoring board may suspend a clinical trial at any time on various grounds, including a finding that the
research subjects or patients are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of
a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if
the drug or biologic has been associated with unexpected serious harm to patients.

Concurrent with clinical trials, companies usually
complete additional animal studies and develop additional information about the chemistry and physical characteristics of the drug or
biologic as well as finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. The
manufacturing process must be capable of consistently producing quality batches of the drug or biological candidate and, among other things,
must include methods for testing the identity, strength, quality and purity of the final drug or biologic. Additionally, appropriate packaging
must be selected and tested and stability studies must be conducted to demonstrate that the drug or biological candidate does not undergo
unacceptable deterioration over its shelf life.

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U.S. Review and Approval Processes

The results of product development, preclinical
studies and clinical trials, along with descriptions of the manufacturing process, analytical tests conducted on the chemistry of the
drug or biologic, proposed labeling and other relevant information are submitted to the FDA as part of an NDA or BLA requesting approval
to market the product. The submission of an NDA or BLA is subject to the payment of substantial user fees; a waiver of such fees may be
obtained under certain limited circumstances.

The FDA reviews all NDAs and BLAs submitted before
it accepts them for filing and may request additional information rather than accepting an NDA or BLA for filing. Once the submission
is accepted for filing, the FDA begins an in-depth review of the NDA or BLA.

After the NDA or BLA submission is accepted for
filing, the FDA reviews the N