Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 146

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 146
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 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 the 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, and, in April 2024, the European Parliament proposed amendments
to the legislative proposals. Once the European Commission’s legislative proposals are approved (with or without amendment), they
will be adopted into EU law.

The United Kingdom left the
European Union on January 31, 2020. As a result of the Northern Ireland protocol, following Brexit, the EMA remained responsible for approving
novel medicines for supply in Northern Ireland under the EU centralized procedure, and a separate authorization was required to supply
the same medicine in Great Britain (England, Wales and Scotland). On February 27, 2023, the United Kingdom government and the European
Commission announced a political agreement in principle to replace the Northern Ireland Protocol with a new set of arrangements, known
as the “Windsor Framework”. The Windsor Framework was approved by the EU-UK Joint Committee on March 24, 2023, and the medicines
aspects of the Windsor Framework have applied since January