Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 186

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 186
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 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.                                                                                      |

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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 unexpected adverse events, any findings from other studies, tests
in laboratory animals or in vitro testing that suggest a significant risk for human subjects, or any clinically important increase in
the rate of serious suspected adverse reactions over those listed in the protocol or investigator brochure. The sponsor must submit an
IND safety report within 15 calendar days after the sponsor determines that the information qualifies for such reporting. The sponsor
also must notify the FDA of any unexpected fatal or life-threatening suspected adverse reaction within 7 calendar days after the
sponsor’s initial receipt of the information. Phase 1, Phase 2, and Phase 3 clinical trials may not be completed
successfully within any specified period, if at all. The FDA or the sponsor or its data safety monitoring board may suspend a clinical
trial at any time on various grounds, including a finding that the research subjects or patients are being exposed to an unacceptable
health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not
being conducted in accordance with the IRB’s requirements or if the biologic has been associated with unexpected serious harm to
patients.

Concurrent with clinical
trials, companies usually complete additional animal studies and must also develop additional information about the physical characteristics
of the biologic as well as finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements.
To help reduce the risk of the introduction of adventitious agents with use of biologics, the PHS Act emphasizes the importance of manufacturing
control for products whose attributes cannot be precisely defined. The manufacturing