Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 89

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 89
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 country to country. In the
U.S., we are not permitted to market our therapeutic product candidates until we receive regulatory approval from the FDA. The process
of obtaining regulatory approval is expensive, often takes many years following research and development and thereafter the commencement
of clinical trials, and can vary substantially based upon the type, complexity, and novelty of the product candidates involved, as well
as the target indications and patient population. Despite the time and expense invested in clinical development of product candidates,
regulatory approval is never guaranteed. For our licensors to gain approval to market our product candidates, they must provide clinical
data that adequately demonstrate the safety and efficacy of the product for the intended indication. We or any third party has not yet
obtained regulatory approval to market any of our product candidates in the U.S. or any other country. Our business depends upon licensing
our therapeutic products to third-party pharmaceutical companies that would obtain these regulatory approvals. The FDA can delay, limit,
or deny approval of these product candidates for many reasons, including:

    ●
    the
    inability of our licensors to satisfactorily demonstrate that the product candidates have acceptable safety and efficacy profiles
    for the requested indication;

    ●
    the
    FDA’s disagreement with the trial designs of our licensors or the interpretation of data from preclinical studies or clinical
    trials;

    ●
    the
    population studied in the clinical trial may not be sufficiently broad or representative to assess safety in the full population
    for which we seek approval;

    ●
    the
    licensors’ inability to demonstrate that clinical or other benefits of our product candidates outweigh any safety or other
    perceived risks;

    ●
    the
    FDA’s determination that additional preclinical or clinical trials are required;

    ●
    the
    FDA’s non-approval of the formulation, labeling, or specifications of our product candidates;

    ●
    the
    FDA’s failure to accept the manufacturing processes, drug product characteristics, or facilities of third-party manufacturers
    with which we or the third-party licensors contract; or

    ●
    the
    potential for approval policies or regulations of the FDA to significantly change in a manner rendering clinical data related to
    any therapeutic product candidate insufficient for approval.

Even
if clinical testing approval of any regulatory filing for our product candidates eventually is completed, the FDA may grant approval
contingent on the performance of costly additional post-approval clinical trials. The FDA may also approve our product candidates for