Company: BIVIW
Filing Date: 2025-07-22
Form Type: S-1/A
Source: 0001520138-25-000216
Chunk: 95

Company: BIOVIE INC.
Filing Date: 2025-07-22
Form: S-1/A
Chunk 95
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, such as a showing of clinical superiority to the product with orphan exclusivity.
Competitors, however, may receive approval of different products for the indication for which the Orphan product has exclusivity or obtain
approval for the same product but for a different indication for which the Orphan product has exclusivity. Orphan product exclusivity
also could block the approval of one of our products for seven years if a competitor obtains approval of the same drug or biological product
as defined by the FDA or if our drug or biological candidate is determined to be contained within the competitor’s product for the
same indication or disease. If a drug or biological product designated as an orphan product receives marketing approval for an indication
broader than what is designated, it 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