Company: LNAI
Filing Date: 2025-02-19
Form Type: 10-K/A
Source: 0001731122-25-000252
Chunk: 22

Company: Lunai Bioworks Inc.
Filing Date: 2025-02-19
Form: 10-K/A
Chunk 22
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<div align='center'>15</div>

Government Regulation

FDA Review and Approval

Government authorities in the United
States, at the federal, state, and local levels, and in other countries extensively regulate, among other things, the research, development,
testing, manufacture, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, post-approval
monitoring and reporting, marketing and export and import of therapeutic products such as those we are developing. Any products we develop
are likely to require regulatory review and allowance to proceed prior to conducting clinical trials and additional regulatory approvals
prior to commercialization. In the United States, the FDA regulates drugs under the Federal Food, Drug and Cosmetic Act (FDCA) and the
Public Health Service Act (PHSA) and their implementing regulations govern, among other things, biopharmaceutical testing, manufacturing,
safety, efficacy, labeling, storage, recordkeeping, advertising, and other promotional practices.

Obtaining FDA approval is a costly
and time-consuming process. FDA approval requires that preclinical studies be conducted in the laboratory and in animal model systems
to gain preliminary information on efficacy and to identify any major safety concerns. The results of these studies are then submitted
as a part of an IND, which the FDA must review and allow before human clinical trials can start. The IND includes a detailed description
of the proposed clinical investigations. An independent Institutional Review Board (“IRB”) must also review and approve the
clinical protocol and each clinical site.

A company must submit
an IND for each investigational medical product and specific indication(s) and must conduct clinical studies to demonstrate the safety
and efficacy of the product necessary to obtain FDA approval. The FDA receives reports on the progress of each phase of clinical testing
and may require the modification, suspension, or termination of clinical trials if an unwarranted risk is observed in participants including
patients.

Obtaining FDA approval prior to
marketing a biopharmaceutical product in the United States typically requires multiple phases of clinical trials to demonstrate the safety
and efficacy of the product candidate. Clinical trials are how experimental treatments are evaluated in humans and are conducted following
preclinical testing. Clinical trials may be conducted within the United States or in foreign countries. If clinical trials are conducted
in foreign countries, the products under development as well as the trials are subject to regulations of the FDA and/or its regulatory
counterparts in the other countries. Upon successful completion of clinical trials, approval to market the