Company: BIVIW
Filing Date: 2025-08-08
Form Type: 424B5
Source: 0001520138-25-000247
Chunk: 90

Company: BIOVIE INC.
Filing Date: 2025-08-08
Form: 424B5
Chunk 90
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, for review, evaluation and a recommendation as to whether the application should be approved and under what conditions.
The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.
During the approval process, the FDA also will determine whether a risk evaluation and mitigation strategy, or REMS, is necessary to assure
the safe use of the drug or biologic. If the FDA concludes that a REMS is needed, the sponsor of the NDA or BLA must submit a proposed
REMS; the FDA will not approve the NDA or BLA without a REMS, if required.

Before approving an NDA or BLA, the FDA will inspect
the facilities at which the product is to be manufactured. The FDA will not approve the product unless it determines that the manufacturing
processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required
specifications. Additionally, before approving an NDA or BLA, the FDA will typically inspect one or more clinical sites to assure compliance
with cGMP. If the FDA determines the application, manufacturing process or manufacturing facilities are not acceptable it will outline
the deficiencies in the submission and often will request additional testing or information.

The NDA or BLA review and approval process is
lengthy and difficult and the FDA may refuse to approve an NDA or BLA if the applicable regulatory criteria are not satisfied or may require
additional clinical data or other information. Even if such data and information is submitted, the FDA may ultimately decide that the
NDA or BLA does not satisfy the criteria for approval. Data obtained from clinical trials are not always conclusive and may be susceptible
to varying interpretations, which could delay, limit or prevent regulatory approval. The FDA will issue a “complete response”
letter if the agency decides not to approve the NDA or BLA. The complete response letter describes all of the specific deficiencies in
the NDA or BLA identified by the FDA. The deficiencies identified may be minor, for example, requiring labeling changes, or major, for
example, requiring additional clinical trials. Additionally, the complete response letter may include recommended actions that the applicant
might take to place the application in a condition for approval. If a complete response letter is issued, the applicant may either resubmit
the NDA or BLA, addressing all of the deficiencies identified in the letter, or withdraw the application.

If a product receives regulatory approval, the
approval may be