Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 188

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 188
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 it is substantially complete before the agency accepts
it for filing. The FDA may refuse to file any BLA that it deems incomplete or not properly reviewable at the time of submission and may
request additional information. In this event, the BLA must be resubmitted with the additional information. The resubmitted application
is also subject to review before the FDA accepts it for filing. The application also needs to be published and submitted in an electronic
format that can be processed through the FDA’s electronic systems. If the electronic submission is not compatible with the FDA’s
systems, the BLA can be refused for filing. Once the submission is accepted for filing, the FDA begins an in-depth substantive review
of the BLA. The FDA reviews the BLA to determine, among other things, whether the proposed product is safe, potent, and effective,
for its intended use, and has an acceptable purity profile, and whether the product is being manufactured in accordance with cGMPs to
assure and preserve the product’s identity, safety, strength, quality, potency and purity. The FDA may refer applications for novel
products or products that present difficult questions of safety or efficacy to an advisory committee, typically a panel that includes
clinicians and other experts, for review, evaluation, and a recommendation as to whether the application should be approved and under
what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully
when making decisions. During the biological product approval process, the FDA also will determine whether 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