Company: BIVIW
Filing Date: 2025-08-08
Form Type: 424B5
Source: 0001520138-25-000247
Chunk: 92

Company: BIOVIE INC.
Filing Date: 2025-08-08
Form: 424B5
Chunk 92
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 may not be entitled to orphan product exclusivity. Orphan Drug status in the European Union has similar
but not identical benefits in the European Union.

Expedited Development and Review Programs

The FDA has a Fast Track program that is intended
to expedite or facilitate the process for reviewing new drug and biological products that meet certain criteria. Specifically, new drug
and biological products are eligible for Fast Track designation if they are intended to treat a serious or life-threatening condition
and demonstrate the potential to address unmet medical needs for the condition. Fast Track designation applies to the combination of the
product and the specific indication for which it is being studied. Unique to a Fast Track product, the FDA may consider for review sections
of the NDA or BLA on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission
of the sections of the NDA or BLA, the FDA agrees to accept sections of the NDA or BLA and determines that the schedule is acceptable,
and the sponsor pays any required user fees upon submission of the first section of the NDA or BLA.

Any product submitted to the FDA for marketing
approval, including those submitted to a Fast Track program, may also be eligible for other types of FDA programs intended to expedite
development and review, such as priority review and accelerated approval. Any product is eligible for priority review if it has the potential
to provide safe and effective therapy where no satisfactory alternative therapy exists or a significant improvement in the treatment,
diagnosis or prevention of a disease compared with marketed products. The FDA will attempt to direct additional resources to the evaluation
of an application for a new drug or biological product designated for priority review in an effort to facilitate the review. Additionally,
a product may be eligible for accelerated approval. Drug or biological products studied for their safety and effectiveness in treating
serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments may receive accelerated
approval, which means that they may be approved on the basis of adequate and well-controlled clinical studies establishing that the product
has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit, or on the basis of an effect on a clinical
endpoint other than survival or irreversible morbidity. As a condition of approval, the FDA generally requires that a sponsor of a drug
or biological product receiving accelerated approval perform adequate and well-controlled post-marketing clinical studies to establish
safety and efficacy for the approved indication. Failure to conduct such studies or conducting such studies that