Company: CERO
Filing Date: 2025-01-21
Form Type: S-1/A
Source: 0001213900-25-004742
Chunk: 169

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-01-21
Form: S-1/A
Chunk 169
---
 animal studies according to Good Laboratory Practices (“GLPs”) and applicable requirements 
 for the humane use of laboratory animals or other applicable regulations;                                                      |

| ● | preparation                                          
 of clinical trial material in accordance with cGMPs; |

| ● | submission                                                                                                               
 to the FDA of an application for an IND application, which must become effective before human clinical trials may begin; |

| ● | approval                                                                                                            
 by an institutional review board (“IRB”), reviewing each clinical site before each clinical trial may be initiated; |

| ● | performance                                                                                                                            
 of adequate and well-controlled human clinical trials according to Good Clinical Practice (“GCP”) requirements and any additional      
 requirements for the protection of human research subjects and their health information, to establish the safety, purity, potency, and 
 efficacy, of the proposed biological product for its intended use;                                                                     |

| ● | submission to the FDA of a Biologics License Application (“BLA”) for marketing approval that includes substantive evidence of safety, purity, potency, and efficacy from results of nonclinical testing and clinical trials; |

| ● | satisfactory                                                                                                                               
 completion of an FDA inspection prior to BLA approval of the manufacturing facility or facilities where the biological product is produced 
 to assess compliance with cGMPs, to assure that the facilities, methods, and controls are adequate to preserve the biologic’s identity,    
 strength, quality, and purity;                                                                                                             |

| ● | potential                                                                                            
 FDA audit of the nonclinical and clinical study sites that generated the data in support of the BLA; |

| ● | potential                                                                                                                    
 FDA advisory committee meeting to elicit expert input on critical issues and including a vote by external committee members; |

108

| ● | FDA                                                                                                      
 review and approval, or licensure, of the BLA, and payment of associated user fees, when applicable; and |

| ● | compliance                                                                                                                                
 with any post-approval requirements, including the potential requirement to implement a Risk Evaluation and Mitigation Strategy (“REMS”), 
 and the potential requirement to conduct post approval studies.                                                                           |

Before testing any biological product candidate in humans, the product candidate enters the preclinical testing stage. Nonclinical tests include laboratory evaluations of product chemistry, pharmacology, toxicity, and formulation, as well as animal studies to assess the potential safety and activity of the product candidate. The conduct of the nonclinical tests must comply with federal regulations and requirements including GLPs. The clinical study sponsor must submit the results of the nonclinical tests, together with manufacturing information