Company: CDT
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0001641172-25-001246
Chunk: 8

Company: CDT Equity Inc.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1A
Chunk 8
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 discretion in the approval process, including the ability to delay, limit, or deny approval
of clinical assets. The delay, limitation, or denial of any regulatory approval would adversely impact commercialization, our potential
to generate revenue, our business, and our operating results.

We
currently have no products approved for sale, and we may never obtain regulatory approval to commercialize any of our current or future
clinical assets. The research, testing, manufacturing, safety surveillance, efficacy, quality control, recordkeeping, labeling, packaging,
storage, approval, sale, marketing, distribution, import, export, and reporting of safety and other post-market information related to
our drug products are subject to extensive regulation by the FDA and other regulatory authorities in the U.S. and in foreign countries,
and such regulations differ from country to country. We are not permitted to market any of our current clinical assets in the U.S. until
we receive approval of an NDA, Biologics License Application (a “BLA”), or other applicable regulatory filing from the FDA.
We are also not permitted to market any of our current clinical assets in any foreign countries until we or our partners receive the
requisite approval from the applicable regulatory authorities of such countries. To gain approval to market a new drug such as AZD1656
and AZD5904, the FDA and/or foreign regulatory authorities must receive, among other things, preclinical and clinical data that adequately
demonstrate the safety, purity, potency, efficacy, and compliant manufacturing of the drug product for the intended indication applied
for in a NDA, BLA, or other applicable regulatory filing. The development and approval of new drug products involves a long, expensive,
and uncertain process, and delay or failure can occur at any stage. A number of companies in the pharmaceutical and biopharmaceutical
industry have suffered significant setbacks in nonclinical development, clinical trials, including in Phase III clinical development,
even after promising results in earlier preclinical studies or clinical trials. These setbacks have been caused by, among other things,
findings made while clinical trials were underway and safety or efficacy observations made in clinical trials, including previously unreported
adverse events. Success in clinical trials does not ensure that later clinical trials will be successful, or that nonclinical studies
will be successful. The results of clinical trials by other parties may not be indicative of the results in trials that we or our partners
may conduct.

The
FDA and foreign regulatory bodies have substantial discretion in the drug development and approval