Company: TELO
Filing Date: 2025-02-04
Form Type: 10-K
Source: 0001493152-25-004872
Chunk: 317

Company: Telomir Pharmaceuticals, Inc.
Filing Date: 2025-02-04
Form: 10-K
Item: Item 1
Chunk 317
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 withdrawn, the value of our business and our operating results may be adversely affected.

33

Any
action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses,
divert our management’s attention from the operation of our business and damage our reputation. We expend significant resources
on compliance efforts and such expenses are unpredictable and might adversely affect our results. Changing laws, regulations and standards
might also create uncertainty, higher expenses and increase insurance costs. As a result, we intend to invest all reasonably necessary
resources to comply with evolving standards, and this investment might result in increased management and administrative expenses and
a diversion of management time and attention from revenue-generating activities to compliance activities.

The
regulatory approval processes with the FDA are lengthy and inherently unpredictable.

We
are not permitted to market our drug candidates as medicines in the United States or other countries until we receive approval of a New
Drug Application (“NDA”) from the FDA or in any foreign countries until we receive the approval from the regulatory authorities
of such countries. Prior to submitting an NDA to the FDA for approval of our drug candidates we will need to have completed our pre-clinical
studies and clinical trials and demonstrate that our products meet all applicable standards of identity, strength, quality, and purity
throughout their expiration date. Successfully completing any clinical program and obtaining approval of an NDA is a complex, lengthy,
expensive, and uncertain process, and the FDA (or other country medicines regulatory body) may delay, limit, or deny approval of product
candidates for many reasons, including, among others, because:

    ●
    an
    inability to demonstrate that our product candidates are safe and effective in treating patients to the satisfaction of the FDA;

    ●
    results
    of clinical trials that may not meet the level of statistical or clinical significance required by the FDA;

    ●
    disagreements
    with the FDA with respect to the number, design, size, conduct or implementation of clinical trials;

    ●
    requirements
    by the FDA to conduct additional clinical trials;

    ●
    disapproval
    by the FDA of certain formulations, labeling or specifications of product candidates;

    ●
    findings
    by the FDA that the data from pre-clinical studies and clinical trials are insufficient;

    ●
    findings
    by the FDA that our API or finished products do not meet all applicable standards of identity, strength, quality, and purity;