Company: APM
Filing Date: 2025-10-06
Form Type: S-4
Source: 0001213900-25-096656
Chunk: 179

Company: Aptorum Group Ltd
Filing Date: 2025-10-06
Form: S-4
Chunk 179
---
 the FDA. The FDA announced in May 2025 that it will not appeal this decision. If the FDA changes its position on this appeal, and wins on appeal, risks associated with the new landscape of LDTs include but are not limited to: •DiamiR’s inability to implement quality standards included in the new guidelines •DiamiR’s inability to implement all FDA requirements for LDTs •Backlog at the FDA for review of submission •Additional regulations being adopted by the FDA •Increased timeline to product launch, delaying revenue for the company •Increased regulatory oversight resulting in delays for product launch •Increased costs of product development and regulatory compliance •Increase costs may arise from: •More expansive validation study design •Hiring additional regulatory compliance talent •Hiring additional statistical experts •Other unanticipated costs Sales of its diagnostic product candidates outside the United States are subject to foreign regulatory requirements governing clinical studies, vigilance reporting, marketing approval, manufacturing, product licensing, pricing and reimbursement. These regulatory requirements vary greatly from country to country. DiamiR may not be able to obtain foreign regulatory approvals on a timely basis or at all. Marketing authorization from the FDA does not ensure approval by regulatory authorities in other countries, and approval by one foreign regulatory authority does not ensure clearance or approval by regulatory authorities in other countries or by the FDA. Foreign regulatory authorities could require additional testing. Failure to comply with foreign regulatory requirements, or to obtain required clearances or approvals, could impair its ability to commercialize its diagnostic product candidates outside of the United States. Global health crises may divert regulatory resources and attention away from approval processes for its products. This could materially lengthen the regulatory approval process of new products, which would delay expected commercialization of such new products. 83 DiamiR and their suppliers, contract manufacturers and customers are subject to various governmental laws and regulations, and DiamiR may incur significant expenses to comply with, and experience delays in DiamiR’s product commercialization as a result of, these laws and regulations. DiamiR’s operations are affected by various state, federal, and international healthcare, environmental, anti -corruption, fraud and abuse (including anti -kickbackand false claims laws), privacy, and employment laws as well as international political sanctions. Violations of these laws and sanctions can result in criminal or civil penalties, including substantial fines and, in some cases, exclusion from participation in federal health care programs such as Medicare and Medicaid. In some cases, the violation of such laws could potentially lead to individual liability and imprisonment. D