Company: CDT
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0001641172-25-001246
Chunk: 9

Company: CDT Equity Inc.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1A
Chunk 9
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 process, including the ability to
delay, limit drug development, or limit or deny approval of clinical assets for many reasons. The FDA or the applicable foreign regulatory
body may:

    ●
    disagree
    with the design or implementation of one or more clinical trials;

    ●
    not
    deem a clinical asset safe and effective for its proposed indication, or may deem a clinical asset’s safety or other perceived
    risks to outweigh its clinical or other benefits;

    ●
    not
    find the data from preclinical studies and clinical trials sufficient to support approval, or the results of clinical trials may
    not meet the level of statistical or clinical significance required by the FDA or the applicable foreign regulatory body for approval;

    ●
    disagree
    with our interpretation of data from preclinical studies or clinical trials performed by us or third parties, or with the interpretation
    of any partner with which we may collaborate;

34

    ●
    determine
    the data collected from preclinical or clinical trials may not be sufficient to support the submission of an Investigational New
    Drug Application (“IND”) or NDA, or other applicable regulatory filing;

    ●
    require
    additional preclinical studies or clinical trials;

    ●
    identify
    deficiencies in the formulation, quality control, labeling, or specifications of our current or future clinical assets;

    ●
    require
    clinical trials in pediatric patients in order to establish pharmacokinetics or safety for this more drug-sensitive population;

    ●
    grant
    approval contingent on the performance of costly additional post-approval clinical trials;

    ●
    approve
    our current or any future clinical assets for a more limited indication or a narrower patient population than we originally requested
    or with strong warnings that may affect marketability;

    ●
    not
    approve the labeling that we believe is necessary or desirable for the successful commercialization of our clinical assets;

    ●
    not
    approve of the manufacturing processes, controls, or facilities of third-party manufacturers or testing labs with which we contract;

    ●
    consider
    our products a device instead of a drug requiring a different approval process and manufacturing needs;

    ●
    consider
    one of our products a combination product instead of a singular drug requiring additional clinical trials or increased number of
    patients per study; or

    ●
    change
    its approval policies or adopt new regulations in a manner rendering our clinical data or regulatory filings insufficient for approval.