Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 134

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 134
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, 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.

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 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