Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 184

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 184
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 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;                                                      |

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| ● | 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, analytical data, any available clinical data
or literature, and a proposed clinical protocol, to the FDA as part of the IND. Some nonclinical testing typically continues after
the IND is submitted. An IND is an exemption that allows an unapproved product to be shipped in interstate commerce for use in an investigational
clinical trial and a request for FDA authorization to administer an investigational product to humans. The IND automatically becomes
effective 30 days after receipt by the FDA, unless the FDA requests certain changes to a protocol before the trial can begin, or
the FDA places the clinical trial on a clinical hold within that 30-day time period. In such a case, the IND sponsor and the FDA must
resolve any outstanding concerns before the clinical trial can begin. The FDA may also impose clinical holds on a biological product
candidate at any time before or during clinical trials due to safety concerns or non-compliance. If the FDA imposes a clinical hold,
tr