Company: CERO
Filing Date: 2025-02-05
Form Type: S-1/A
Source: 0001213900-25-010230
Chunk: 173

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-05
Form: S-1/A
Chunk 173
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 GCP requirements, including the requirement that all research subjects or his or her legal representative provide informed consent. Further, each clinical trial must be reviewed and approved by an independent IRB, at or servicing each institution at which the clinical trial will be conducted. An IRB is charged with protecting the welfare and rights of study participants and considers such items as whether the risks to individuals participating in the clinical trials are minimized and are reasonable in relation to anticipated benefits. The IRB also approves the form and content of the informed consent that must be signed by each clinical trial subject or his or her legal representative and must monitor the clinical trial until completed. Additionally, some trials are overseen by an independent group of qualified experts organized by the trial sponsor, known as a data safety monitoring board or committee. Human clinical trials are typically conducted in three sequential phases that may overlap or be combined:

| ● | Phase                                                                                                                             
 1. The biological product is initially introduced into healthy human subjects and tested for safety. In the case of some products 
 for rare diseases, the initial human testing is often conducted in patients.                                                      |

| ● | Phase                                                                                                                                  
 2. The biological product is evaluated in a limited patient population to identify possible adverse effects and safety risks,          
 preliminarily evaluate the efficacy of the product for specific targeted diseases, and determine dosage tolerance, optimal dosage, and 
 dosing schedule.                                                                                                                       |

| ● | Phase                                                                                                                                    
 3. Clinical trials are undertaken to further evaluate dosage, clinical efficacy, potency, and safety in an expanded patient population   
 at geographically dispersed clinical trial sites. These clinical trials are intended to establish the overall risk/benefit ratio of the  
 product and provide an adequate basis for product labeling. In biologics for rare diseases where patient populations are small and there 
 is an urgent need for treatment, Phase 3 trials might not be required if an adequate risk/benefit can be demonstrated by the Phase 2     
 trial.                                                                                                                                   |

109 Post-approval clinical trials, sometimes referred to as Phase 4 clinical trials, may be conducted after initial marketing approval. These clinical trials are used to gain additional experience from the treatment of patients in the intended therapeutic indication, particularly for long-term safety follow-up. During all phases of clinical development, the FDA requires extensive monitoring and auditing of all clinical activities, clinical data, and clinical trial investigators. Annual progress reports detailing the results of the clinical trials must be submitted to the FDA. Written IND safety reports must be promptly submitted to the FDA and the investigators for serious and