Company: REVB
Filing Date: 2025-05-23
Form Type: S-1/A
Source: 0001213900-25-047104
Chunk: 113

Company: REVELATION BIOSCIENCES, INC.
Filing Date: 2025-05-23
Form: S-1/A
Chunk 113
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 accordance with good laboratory practice (“GLP”) requirements; |

| ● | completion of the manufacture, under current Good Manufacturing                                                          
 Practices (“cGMP”), conditions, of the drug substance and drug product that the sponsor intends to use in human clinical 
 trials along with required analytical and stability testing;                                                             |

| ● | submission to the FDA of an investigational new drug application,                                                                    
 or IND, which must become effective before clinical trials may begin and must be updated annually and when certain changes are made; |

| ● | approval by an institutional review board (“IRB”),                                              
 or independent ethics committee at each clinical trial site before each trial may be initiated; |

| ● | performance of adequate and well-controlled clinical trials                                                                  
 in accordance with applicable IND regulations, good clinical practice (“GCP”), requirements and other clinical trial-related 
 regulations to establish the safety and efficacy of the investigational product for each proposed indication;                |

| ● | preparation and submission to the FDA of an NDA; |

| ● | a determination by the FDA within 60 days of its receipt 
 of an NDA to file the application for review;            |

| ● | satisfactory completion of one or more FDA pre-approval inspections                                                                    
 of the manufacturing facility or facilities where the drug will be produced to assess compliance with cGMP requirements to assure that 
 the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity;                       |

| ● | satisfactory completion of FDA audit of the clinical trial 
 sites that generated the data in support of the NDA;       |

| ● | payment of user fees for FDA review of the NDA; and |

| ● | FDA review and approval of the NDA, including, where applicable,                                                                      
 consideration of the views of any FDA advisory committee, prior to any commercial marketing or sale of the drug in the United States. |

Preclinical studies and the IND process Preclinical studies include laboratory evaluation of product chemistry and formulation, as well as in vitro and animal studies to assess the potential for adverse events and in some cases to establish a rationale for therapeutic use. The conduct of preclinical studies is subject to federal regulations and requirements, including GLP regulations. An IND sponsor must submit the results of the preclinical tests, together with manufacturing information, analytical data, any available clinical data or literature and a proposed protocol for clinical studies, among other things, to the FDA as part of an IND. An IND is an exemption from the FD&C Act that allows an un