Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 200

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 200
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UMA”). If a PUMA
is granted, the product will benefit from ten years of market protection as an incentive.

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In March 2016, the
EMA launched an initiative, the PRIority MEdicines (“PRIME”) scheme, to facilitate development of product candidates in indications,
often rare, for which few or no therapies currently exist. The PRIME scheme is intended to encourage development of products in areas
of unmet medical need and provides accelerated assessment of products representing substantial innovation reviewed under the centralized
procedure. Products from small- and medium-sized enterprises may qualify for earlier entry into the PRIME scheme than larger companies
on the basis of compelling non-clinical data and tolerability data from initial clinical trials. Many benefits accrue to sponsors of
product candidates with PRIME designation, including but not limited to, early and proactive regulatory dialogue with the EMA, frequent
discussions on clinical trial designs and other development program elements, and potentially accelerated MAA assessment once a dossier
has been submitted. Importantly, once a candidate medicine has been selected for the PRIME scheme, a dedicated contact and rapporteur
from the CHMP or from the Committee for Advanced Therapies (“CAT”) are appointed early in the PRIME scheme facilitating increased
understanding of the product at EMA’s committee level. An initial meeting with the CHMP/CAT rapporteur initiates these relationships
and includes a team of multidisciplinary experts at the EMA to provide guidance on the overall development and regulatory strategies.
PRIME eligibility does not change the standards for product approval, and there is no assurance that any such designation or eligibility
will result in expedited review or approval.

The aforementioned European
Union rules are generally applicable in the EEA.

The European Commission
introduced legislative proposals in April 2023 that, if implemented, will replace the current regulatory framework in the European Union
for all medicines (including those for rare diseases and for children). The European Commission has provided the legislative proposals
to the European Parliament and the European Council for their review and approval. In October 2023, the European Parliament published
draft reports proposing amendments to the legislative proposals, which will be debated by the European Parliament. Once the European
Commission’s legislative proposals are approved (with or without amendment), they will be adopted into European Union law.

The United Kingdom left
the European Union on January 31, 2020, and the United Kingdom and the European Union have