Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 33

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 33
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 the effectiveness
criteria to be evaluated. Each protocol involving testing on U.S. patients and subsequent protocol amendments must be submitted to the
FDA as part of the IND.

The
FDA may order the temporary or permanent discontinuation of a clinical trial at any time or impose other sanctions if it believes that
the clinical trial either is not being conducted in accordance with FDA regulations or presents an unacceptable risk to the clinical
trial patients. Imposition of a clinical hold may be full or partial. The study protocol and informed consent information for patients
in clinical trials must also be submitted to an IRB for approval. The IRB will also monitor the clinical trial until completed. An IRB
may also require the clinical trial at the site to be halted, either temporarily or permanently, for failure to comply with the IRB’s
requirements or may impose other conditions. Additionally, some clinical trials are overseen by an independent group of qualified experts
organized by the clinical trial sponsor, known as a data safety monitoring board or committee. This group provides authorization for
whether a trial may move forward at designated checkpoints based on access to certain data from the trial.

Clinical
trials to support NDAs for marketing authorization are typically conducted in three sequential phases, which may overlap or be combined.
In Phase 1, the initial introduction of the drug into patients, the product is tested to assess safety, dosage tolerance, metabolism,
pharmacokinetics, pharmacological actions, side effects associated with drug exposure, and to obtain early evidence of a treatment effect
if possible. Phase 2 usually involves trials in a limited patient population to determine the effectiveness of the drug for a particular
indication, determine optimal dose and regimen, and to identify common adverse effects and safety risks. If a compound demonstrates evidence
of effectiveness and an acceptable safety profile in Phase 2 evaluations, Phase 3 trials are undertaken to obtain additional information
about clinical effects and confirm efficacy and safety in a larger number of patients, typically at geographically dispersed clinical
trial sites, to permit the FDA to evaluate the overall benefit-risk relationship of the drug and to provide adequate information for
the labeling of the product. In most cases, the FDA requires two adequate and well-controlled Phase 3 clinical trials to demonstrate
the safety and efficacy of the drug. In rare instances, a single Phase 3 trial may be sufficient when either (1) the trial is a large,
multicenter trial demonstrating internal consistency and a statistically very persuasive finding of a clinically meaningful effect on
mortality, irreversible