Company: BIVIW
Filing Date: 2025-07-11
Form Type: S-1/A
Source: 0001520138-25-000205
Chunk: 91

Company: BIOVIE INC.
Filing Date: 2025-07-11
Form: S-1/A
Chunk 91
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 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 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