Company: TELO
Filing Date: 2025-02-04
Form Type: 10-K
Source: 0001493152-25-004872
Chunk: 289

Company: Telomir Pharmaceuticals, Inc.
Filing Date: 2025-02-04
Form: 10-K
Item: Item 1
Chunk 289
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 chemistry, formulation, and stability, as well as studies to evaluate
toxicity in animals, to assess the potential for adverse events (“AEs”) and, in some cases, to establish a rationale for
therapeutic use. The conduct of pre-clinical studies is subject to federal regulations and requirements, including GLP regulations for
safety/toxicology studies. An IND sponsor must submit the results of the pre-clinical studies, together with manufacturing information,
analytical data, any available clinical data or literature and a proposed clinical protocol, to the FDA as part of the IND.

An
IND is a request for authorization from the FDA to ship an investigation product and then administer it to humans and must be allowed
to proceed by the FDA before human clinical trials may begin. Some long-term pre-clinical testing, such as animal tests of reproductive
AEs and carcinogenicity, may continue after the IND is submitted. An IND automatically becomes effective 30 days after receipt by the
FDA, unless the FDA raises concerns or questions before that time related to one or more proposed clinical trials and places the trial
on clinical hold. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin.
As a result, submission of an IND may not result in the FDA allowing clinical trials to commence.

Clinical
trials

The
clinical stage of development involves the administration of the investigational product to healthy volunteers or patients under the
supervision of qualified investigators, generally physicians not employed by, or under control of, the trial sponsor, in accordance with
GCPs, which include the requirement that all research patients provide their informed consent for their participation in any clinical
trial. Clinical trials are conducted under protocols detailing, among other things, the objectives of the clinical trial, dosing procedures,
subject selection and exclusion criteria and the parameters to be used to monitor subject safety and assess efficacy. Each protocol,
and any subsequent amendments to the protocol, must be submitted to the FDA as part of the IND. Furthermore, each clinical trial must
be reviewed and approved by an IRB for each institution at which the clinical trial will be conducted to ensure that the risks to individuals
participating in the clinical trials are minimized and are reasonable in relation to anticipated benefits. The IRB also approves the
informed consent form that must be provided to each clinical trial subject or his or her legal representative and must monitor the clinical
trial until completed. There also are requirements governing