Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 187

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 187
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 process must be capable of consistently producing
quality batches of the product candidate and, among other things, the sponsor must develop methods for testing the identity, strength,
quality, potency, and purity of the final biological product. Additionally, appropriate packaging must be selected and tested and stability
studies must be conducted to demonstrate that the biological product candidate does not undergo unacceptable deterioration over its shelf
life.

There are also various laws
and regulations regarding laboratory practices, the experimental use of animals, and the use and disposal of hazardous or potentially
hazardous substances in connection with the research. In each of these areas, the FDA and other regulatory authorities have broad regulatory
and enforcement powers, including the ability to levy fines and civil penalties, suspend or delay issuance of approvals, seize or recall
products, and withdraw approvals.

Information about certain
clinical trials must be submitted within specific timeframes for public dissemination on the clinicaltrials.gov website. Sponsors or
distributors of investigational products for the diagnosis, monitoring, or treatment of one or more serious diseases or conditions must
also have a publicly available policy on evaluating and responding to requests for expanded access requests.

U.S. Review and Approval Processes

After the completion of
clinical trials of a biological product, FDA approval of a BLA must be obtained before commercial marketing of the product begins. The
BLA must include results of product development, laboratory, and animal studies, human studies, information on the manufacture and composition
of the product, proposed labeling, and other relevant information. The testing and approval processes require substantial time and effort
and there can be no assurance that the FDA will accept the BLA for filing and, even if filed, that any approval will be granted on a
timely basis, if at all.

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Under the Prescription Drug
User Fee Act, as amended (“PDUFA”), each BLA may be accompanied by a significant user fee. Under federal law, the submission
of most applications is subject to an application user fee. The sponsor of an approved application is also subject to an annual program
fee. Fee waivers or reductions are available in certain circumstances, including a waiver of the application fee for the first application
filed by a small business. Additionally, no user fees are assessed on BLAs for product candidates designated as orphan drugs, unless
the product candidate also includes a non-orphan indication.

Within 60 days following
submission of the application, the FDA reviews a BLA submitted to determine if