Company: TELO
Filing Date: 2025-02-04
Form Type: 10-K
Source: 0001493152-25-004872
Chunk: 288

Company: Telomir Pharmaceuticals, Inc.
Filing Date: 2025-02-04
Form: 10-K
Item: Item 1
Chunk 288
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 after approval, may subject an applicant to a variety of administrative
or judicial sanctions, such as the FDA’s refusal to approve pending New Drug Applications (NDAs), withdrawal of an approval, imposition
of a clinical hold, issuance of warning letters, product recalls, product seizures, total or partial suspension of production or distribution,
injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties. The process required
by the FDA before a drug may be marketed in the United States generally involves the following:

    ●
    completion
    of pre-clinical laboratory tests, animal studies and formulation studies in compliance with the FDA’s good laboratory practice
    (“GLP”) regulations; 

    ●
    submission
    to the FDA of an IND application, which must become effective before human clinical trials may begin;

    ●
    approval
    by an independent Institutional Review Board (“IRB”), at each clinical site before each trial may be initiated;

15

    ●
    performance
    of adequate and well-controlled human clinical trials in accordance with good clinical practices (“GCP”) requirements
    to establish the safety and efficacy of the proposed drug product for each indication;

    ●
    demonstration
    that the API and finished product are manufactured under cGMP conditions and meet all applicable standards of identity, strength,
    quality, and purity;

    ●
    submission
    to the FDA of an NDA;

    ●
    satisfactory
    completion of an FDA advisory committee review, if applicable;

    ●
    satisfactory
    completion of an FDA inspection of the manufacturing facility or facilities at which the product is produced to assess compliance
    with cGMP requirements and to assure that the facilities, methods, and controls are adequate to preserve the drug’s identity,
    strength, quality, and purity;

    ●
    FDA
    review and approval of the NDA, including consideration of the views of any FDA advisory committee, prior to commercial marketing
    or sale of the drug in the United States; and

    ●
    compliance
    with any post-approval requirements, including the potential requirement to implement a Risk Evaluation and Mitigation Strategy (“REMS”)
    or to conduct a post-approval study.

Pre-clinical
studies

Before
testing any drug or biological product candidate in humans, the product candidate must undergo rigorous pre-clinical testing. The pre-clinical
developmental stage generally involves laboratory evaluations of drug