Company: BIVIW
Filing Date: 2025-08-08
Form Type: 424B5
Source: 0001520138-25-000247
Chunk: 87

Company: BIOVIE INC.
Filing Date: 2025-08-08
Form: 424B5
Chunk 87
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 United States generally involves the following:

| · | Completion of preclinical laboratory tests, animal studies and formulation studies according to Good Laboratory 
 Practices or other applicable regulations;                                                                      |

| · | Submission to the FDA of an Investigational New Drug Application (“IND”), which must become 
 effective before human clinical trials may begin;                                           |

| · | Performance of adequate and well-controlled human clinical trials according to the FDA’s GCPs, to 
 establish the safety and efficacy of the proposed drug or biologic for its intended use;          |

| · | Submission to the FDA of a New Drug Application (an “NDA”), for a new drug product, or a Biologics 
 License Application (a “BLA”), for a new biological product;                                       |

| · | Satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the drug                             
 or biologic is to be produced to assess compliance with the FDA’s current good manufacturing practice standards, or cGMP, to assure 
 that the facilities, methods and controls are adequate to preserve the drug’s or biologic’s identity, strength, quality and         
 purity;                                                                                                                             |

| · | Potential FDA audit of the nonclinical and clinical trial sites that generated the data in support of 
 the NDA or BLA; and                                                                                   |

| · | FDA review and approval of the NDA or BLA. |

The lengthy process of seeking required approvals
and the continuing need for compliance with applicable statutes and regulations require the expenditure of substantial resources. There
can be no certainty that approvals will be granted.

Clinical trials involve the administration of
the drug or biological candidate to healthy volunteers or patients having the disease being studied under the supervision of qualified
investigators, generally physicians not employed by or under the trial sponsor’s control. Clinical trials are conducted under protocols
detailing, among other things, the objectives of the clinical trial, dosing procedures, subject selection and exclusion criteria, and
the parameters to be used to monitor subject safety. Each protocol must be submitted to the FDA as part of the IND. Clinical trials must
be conducted in accordance with the FDA’s cGCP requirements. Further, each clinical trial must be reviewed and approved by an independent
institutional review board (“IRB”), at or servicing each institution at which the clinical trial will be conducted. An IRB
is charged with protecting the welfare and rights of trial participants and considers such items as whether the risks to individuals participating
in the clinical trials are minimized and are reasonable in relation