Company: TELO
Filing Date: 2025-02-04
Form Type: 10-K
Source: 0001493152-25-004872
Chunk: 291

Company: Telomir Pharmaceuticals, Inc.
Filing Date: 2025-02-04
Form: 10-K
Item: Item 1
Chunk 291
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 to the FDA and more frequently if significant
adverse events (“SAEs”) occur. The FDA or the sponsor may suspend or terminate a clinical trial at any time, or the FDA may
impose other sanctions on various grounds, including a finding that the research patients are being exposed to an unacceptable health
risk. Similarly, an IRB can refuse, suspend, or terminate approval of a clinical trial at its institution if the clinical trial is not
being conducted in accordance with the IRB’s requirements or if the drug has been associated with unexpected serious harm to patients.

Concurrently
with clinical trials, companies usually complete additional pre-clinical studies and must also develop additional information about the
physical characteristics of the drug or biological product as well as finalize a process for manufacturing the product in commercial
quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches
of the product candidate and, among other things, the sponsor must develop methods for testing the identity, strength, quality, potency,
and purity of the final biological product. Additionally, appropriate packaging must be selected and tested, and stability studies must
be conducted to demonstrate that the biological product candidate does not undergo unacceptable deterioration over its shelf life.

Marketing
Approval

Assuming
successful completion of the required clinical testing, the results of the pre-clinical studies and clinical trials, together with detailed
information relating to the product’s chemistry, manufacture, controls, and proposed labeling, are submitted
to the FDA as part of an NDA requesting approval to market the product for one or more indications. In most cases, the submission of
an NDA is subject to a substantial application user fee.

17

The
review process typically takes twelve months from the date the NDA is submitted to the FDA. The FDA conducts a preliminary review of
all NDAs within the first 60 days after submission to determine whether they are sufficiently complete to permit substantive review before
accepting them for “filing.” The FDA may request additional information rather than accept an NDA for filing. In this event,
the application must be resubmitted with the additional information and may be subject to an additional application user fee. The resubmitted
application is also subject to review before the FDA accepts it for filing. Once the submission is accepted for filing, the FDA begins
an in-depth substantive review. The FDA reviews an NDA to determine, among other things, whether the drug is safe and effective and whether
the facility in which it is