Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 123

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 123
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conduct additional clinical and non-clinical testing in addition to those we have planned. Our failure to adequately demonstrate the safety
and efficacy of our current or future product candidates would prevent receipt of regulatory approval or certification. Further, regulators
may determine that our financial relationships with certain principal investigators who provide us with consulting services from time
to time for which we separately compensate them resulted in a perceived or actual conflict of interest that may have affected the interpretation
of a study, the integrity of the data generated at the applicable clinical study site or the utility of the clinical study itself. Even
if our future products are approved in the United States, commercialization of our product candidates in foreign countries would require
approval by regulatory authorities in those countries. Approval and certification procedures vary among jurisdictions and can involve
requirements and administrative review periods different from, and greater than, those in the United States, including additional preclinical
studies or clinical studies. Any of these occurrences could have an adverse effect on our business, financial condition, and results of
operations.

The ability to
successfully initiate, enroll and complete a clinical trial in any country outside of the U.S., should we decide to do so, is subject
to numerous risks unique to conducting business in such countries, including:

| ● | difficulty in establishing or managing relationships with contract research organizations, or CROs, and 
 physicians;                                                                                             |

| ● | different or additional standards for the conduct of clinical trials; |

| ● | absence in some countries of established groups with sufficient regulatory expertise for review of the 
 protocols;                                                                                             |

| ● | ensuring that clinical trial quality is sufficient to meet the standard of the FDA or other regulatory 
 authorities;                                                                                           |

| ● | inability to locate qualified local consultants, physicians and partners; and |

| ● | the potential burden of complying with a variety of non-U.S. laws, medical standards and regulatory requirements, 
 including the regulation of medical device, pharmaceutical and biotechnology products or combination products.    |

Clinical studies
must be conducted in accordance with the laws and regulations enforced by the FDA and other regulatory authority requirements, and are
subject to oversight by these governmental agencies and Institutional Review Boards (“IRBs”). In addition, clinical studies
must be conducted with supplies of our product candidates produced under cGMP, requirements. Furthermore, we rely on CROs and clinical
study sites to ensure the proper and timely conduct of our clinical studies and while we have agreements governing their committed activities,
we have limited influence over their actual performance.