Company: BIVIW
Filing Date: 2025-08-08
Form Type: 424B5
Source: 0001520138-25-000247
Chunk: 88

Company: BIOVIE INC.
Filing Date: 2025-08-08
Form: 424B5
Chunk 88
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 to anticipated benefits. The IRB also approves the informed consent
form that must be provided to each clinical trial subject or his or her legal representative and must monitor the clinical trial until
it is completed.

Human clinical trials prior to approval are typically
conducted in three sequential phases that may overlap or be combined:

| · | Phase 1. The drug or biologic is initially introduced into healthy human subjects and tested for                                           
 safety, dosage tolerance, absorption, metabolism, distribution and excretion. In the case of some products for severe or life-threatening  
 diseases, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing 
 is often conducted in patients having the specific disease.                                                                                |

| · | Phase 2. The drug or biologic is evaluated in a limited patient population to identify possible                                         
 adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine 
 optimal dosage and dosing schedule for patients having the specific disease.                                                            |

| · | Phase 3. Clinical trials are undertaken to further evaluate dosage, clinical efficacy and safety                                        
 in an expanded patient population at geographically dispersed clinical trial sites. These clinical trials, which usually involve more   
 subjects than earlier trials, are intended to establish the overall risk/benefit ratio of the product and provide an adequate basis for 
 product labeling. Generally, two adequate and well-controlled Phase 3 clinical trials are required by the FDA for approval of an NDA or 
 BLA.                                                                                                                                    |

Post-approval studies, or Phase 4 clinical trials,
may be conducted after initial marketing approval. These studies are used to gain additional experience from the treatment of patients
in the intended therapeutic indication and may be required by the FDA as part 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