Company: REVB
Filing Date: 2025-05-20
Form Type: S-1
Source: 0001213900-25-045828
Chunk: 115

Company: REVELATION BIOSCIENCES, INC.
Filing Date: 2025-05-20
Form: S-1
Chunk 115
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, metabolism, distribution, excretion and, if possible, to gain an   
 early indication of its effectiveness.                                                                                                   |

| ● | Phase 2: The investigational drug or biological product                                                                                     
 is administered to a limited patient population to identify common adverse effects and safety risks, to preliminarily evaluate the efficacy 
 of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage. This phase may include administration   
 of the investigational drug to patients with concomitant disease conditions.                                                                |

| ● | Phase 3: The investigational drug or biological product                                                                                   
 is administered to an expanded patient population in adequate and well-controlled clinical studies, typically at geographically dispersed 
 clinical study sites, to generate sufficient data to statistically confirm the efficacy and safety of the product for approval, to permit 
 the FDA to evaluate the overall risk-benefit profile of the product and to provide adequate information for the labeling of the product.  
 More than one adequate and well-controlled Phase 3 clinical study may be required by the FDA for approval of an NDA.                      |

Progress reports detailing the results of clinical studies involving an IND must be submitted at least annually to the FDA and more frequently if serious adverse events occur. Phase 1, Phase 2 and Phase 3 clinical studies may not be completed successfully within any specified period, or at all. Furthermore, the FDA or the sponsor may suspend or terminate a clinical study at any time on various grounds, including a finding that the research subjects are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical study at its institution if the clinical study is not being conducted in accordance with the IRB’s requirements or if the drug or biologic product has been associated with unexpected serious harm to patients. Concurrent with clinical studies, the company usually complete additional animal studies, develop additional information about chemistry and physical characteristics of the product candidate, and finalize a process for manufacturing the drug product in commercial quantities in accordance with cGMP requirements. The manufacturing must be capable of consistently producing quality batches of the product candidate and manufacturers must develop, among other things, methods for testing the identity, strength, quality and purity of the final drug product. Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life. In some cases, the FDA may approve an application for a product candidate but require the sponsor to conduct additional clinical studies to further assess the product candidate’s safety and effectiveness