Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 183

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 183
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 be competitive with them. Some of
these drugs are branded and subject to patent protection, and others are available on a generic basis. Insurers and other third-party
payors may also encourage the use of generic products or specific branded products. As a result, obtaining market acceptance of any of
our CER-T cell therapies that we successfully introduce to the market may pose challenges.

Government Regulation

In the United States,
biological products are licensed by the FDA for marketing under the Public Health Service Act (“PHS Act”) and regulated under
the Federal Food, Drug, and Cosmetic Act (“FDCA”). Both the FDCA and the PHS Act and their corresponding regulations govern,
among other things, the testing, manufacturing, safety, purity, potency, efficacy, labeling, packaging, storage, recordkeeping, distribution,
marketing, sales, import, export, reporting, advertising, and other promotional practices involving biological products. FDA clearance
of an IND application must be obtained before commencing clinical testing of biological products. FDA licensure also must be obtained
before marketing of biological products. The process of obtaining regulatory approvals and the subsequent compliance with appropriate
federal, state, local, and foreign statutes and regulations require the expenditure of substantial time and financial resources.

U.S. Development Process

The process required by the FDA before a biological
product may be marketed in the United States generally involves the following:

| ● | completion                                                                                
 of nonclinical laboratory tests and 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