Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 135

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 135
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 a REMS is necessary to assure the safe use of the
biological product. If the FDA concludes a REMS is needed, the sponsor of the BLA must submit a proposed REMS; the FDA will not approve
the BLA without a REMS, if required.

Before approving a BLA, the
FDA may inspect the facilities at which the product is manufactured. The FDA will not approve the product unless it determines that the
manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product
within required specifications. Additionally, before approving a BLA, the FDA will typically inspect one or more clinical trial sites
to assure that the clinical trials were conducted in compliance with IND study requirements and GCP requirements. To assure cGMP and GCP
compliance, an applicant must incur significant expenditure of time, money, and effort in the areas of training, record keeping, production
and quality control.

Notwithstanding the submission
of relevant data and information, the FDA may ultimately decide that the BLA does not satisfy its regulatory criteria for approval and
deny approval. Data obtained from clinical trials are not always conclusive and the FDA may interpret data differently than the sponsor
interprets the same data. If the agency decides not to approve the BLA in its present form, the FDA will issue a complete response letter
that describes all of the specific deficiencies in the BLA identified by the FDA. The deficiencies identified may be minor, such as requiring
labeling changes, or major, such as requiring additional clinical trials. Additionally, the complete response letter may include recommended
actions that the applicant might take to place the application in a condition for approval. If a complete response letter is issued, the
applicant may either resubmit the BLA, addressing all of the deficiencies identified in the letter, or withdraw the application.

If a product receives regulatory
approval, the approval may be significantly limited to specific diseases and dosages or the indications for use may otherwise be limited,
which could restrict the commercial value of the product. Further, the FDA may require that certain contraindications, warnings, or precautions
be included in the product labeling. The FDA may impose restrictions and conditions on product distribution, prescribing, or dispensing
in the form of a risk management plan, or otherwise limit the scope of any approval. In addition, the FDA may require post-marketing clinical
trials, sometimes referred to as Phase 4 clinical trials, designed to further assess a biological