Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 205

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 205
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agreement to conduct, in a diligent manner, additional post-approval confirmatory studies to verity and describe the drug’s clinical
benefit. Under the FDORA, the FDA is permitted to require, as appropriate, that a post-approval confirmatory study or studies be underway
prior to approval or within a specified time period after the date of accelerated approval was granted. FDORA also requires sponsors to
send updates to the FDA every 180 days on the status of such studies, including progress toward enrollment targets, and the FDA must promptly
post this information publicly. FDORA also gives the FDA increased authority to withdraw approval of a drug or biologic granted accelerated
approval on an expedited basis if the sponsor fails to conduct such studies in a timely manner, send the necessary updates to the FDA,
or if such post-approval studies fail to verify the drug’s predicted clinical benefit. Under FDORA, the FDA is empowered to take
action, such as issuing fines, against companies that fail to conduct with due diligence any post-approval confirmatory study or submit
timely reports to the agency on their progress. In addition, the FDA currently requires, unless otherwise informed by the agency, pre-approval
of promotional materials for products receiving accelerated approval, which could adversely impact the timing of the commercial launch
of the product. Thus, even if we seek to utilize the accelerated approval pathway, we may not be able to obtain accelerated approval and,
even if we do, we may not experience a faster development, regulatory review or approval process for that product. There can be no assurance
that the FDA would allow any of the product candidates we may develop to proceed on an accelerated approval pathway, and even if the FDA
did allow such pathway, there can be no assurance that such submission or application will be accepted or that any expedited development,
review or approval will be granted on a timely basis, or at all. Moreover, even if we received accelerated approval, any post-approval
studies required to confirm and verify clinical benefit may not show such benefit, which could lead to withdrawal of any approvals we
have obtained. Receiving accelerated approval does not assure that the product’s accelerated approval will eventually be converted
to a traditional approval.

We may not be able to obtain orphan drug
exclusivity for one or more of our product candidates, and even if we do, that exclusivity may not prevent the FDA from approving other
competing products.

Regulatory authorities may
designate drugs for relatively small patient populations as