Company: CERO
Filing Date: 2025-05-27
Form Type: POS AM
Source: 0001213900-25-047469
Chunk: 180

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-05-27
Form: POS AM
Chunk 180
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 with testing in patients with the disease. Clinical trials are conducted under protocols detailing, among other things, the objectives of the clinical trial, dosing procedures, subject selection, and exclusion criteria, and the parameters to be used to monitor subject safety, including stopping rules that assure a clinical trial will be stopped if certain adverse events should occur. Each protocol and any amendments to the protocol must be submitted to the FDA as part of the IND. Clinical trials must be conducted and monitored in accordance with the FDA’s regulations comprising the 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.                    |

Post-approval clinical trials, sometimes referred to as Phase 4 clinical trials