Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 124

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 124
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 We depend on our collaborators, medical institutions and CROs to conduct our
clinical studies in compliance with GCP requirements. To the extent our collaborators or the CROs fail to enroll participants for our
clinical studies, fail to conduct the study according to GCP requirements or are delayed for a significant time in the execution of trials,
including achieving full enrollment, we may be affected by increased costs, program delays or both.

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In addition,
clinical studies that are conducted in countries outside the United States may subject us to further delays and expenses as a result of
increased shipment costs, additional regulatory requirements and the engagement of non-U.S. CROs, as well as expose us to risks associated
with clinical investigators who are unknown to the FDA, and different standards of diagnosis, screening and medical care. Further, the
FDA or other foreign regulatory authorities may not accept data from trials conducted outside their jurisdiction. In cases where data
from foreign clinical trials are intended to serve as the basis for marketing approval in the United States, the FDA will generally not
approve the application on the basis of foreign data alone unless (i) the data are applicable to the U.S. population and U.S. medical
practice; and (ii) the trials were performed by clinical investigators of recognized competence and pursuant to good clinical practice
(GCP) regulations; and (iii) the data may be considered valid without the need for an on-site inspection by the FDA, or if the FDA considers
such inspection to be necessary, the FDA is able to validate the data through an on-site inspection or other appropriate means. In general,
the patient population for any clinical trials conducted outside the United States must be representative of the population for whom we
intend to label the product candidate in the United States. Additionally, the FDA’s clinical trial requirements, including sufficient
size of patient populations and statistical powering, must be met. Many foreign regulatory authorities have similar approval requirements
for clinical trials. In addition, such trials would be subject to the applicable local laws of the foreign jurisdictions where the trials
are conducted. There can be no assurance that the FDA or any comparable foreign regulatory authority will accept data from trials conducted
outside of the applicable jurisdiction. If the FDA or any comparable foreign regulatory authority does not accept such data, it would
result in the need for additional trials, which could be costly and time-consuming, and which may result in product candidates that we
may develop not receiving approval for commercialization in the applicable jurisdiction. Even if