Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 121

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 121
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 and/or potency of the product candidate. Clinical development is a long, expensive and uncertain process and is subject
to delays and to the risk that products may ultimately prove unsafe, ineffective, impure and/or impotent in treating the indications for
which they are designed. Completion of the clinical studies required to support a marketing authorization (inclusive of any application
or approval for clinical use or commercial sale in a given market) usually takes several years or more. We cannot assure you that we will
successfully complete clinical testing of our products within the periods we have planned, or at all. Further, even if we achieve positive
interim or preliminary results in clinical studies, these results do not necessarily predict final results, and positive results in early
trials do not necessarily indicate success in later trials. Moreover, preclinical and clinical data are often susceptible to varying interpretations
and analyses, and many companies have suffered significant setbacks in advanced clinical studies, even after receiving positive results
in earlier trials. Any of our products may malfunction or may produce undesirable adverse effects that could cause us or regulatory authorities
to interrupt, delay or halt clinical studies. We, the FDA, or another regulatory authority may suspend or terminate clinical studies at
any time to avoid exposing trial participants to unacceptable health risks.

Additionally,
the FDA or other regulatory bodies may disagree with our interpretation of the data from our preclinical studies and clinical studies,
or may find the clinical study design, conduct or results inadequate to prove safety, efficacy, purity and/or potency and may require
us to pursue additional preclinical studies or clinical studies, which could further delay or prevent the approval or certification of
our products. The data we collect from our preclinical studies and clinical studies may not be sufficient to support potential FDA approval
or certification, and if we are unable to demonstrate the safety and efficacy of our product candidates in our clinical studies, we will
be unable to obtain regulatory approval or certification to market our products.

As a result,
we may experience numerous unforeseen events during, or because of, the clinical study process that could delay or prevent us from receiving
regulatory approval or certification for new products, modification of existing products, or approval or certification of new indications
for existing products. These unforeseen events may include:

| ● | delays or failures in obtaining regulatory authorization from the FDA or other regulatory authorities 
 to commence a clinical study;                                                                         |

| ● | delays in reaching agreement on acceptable terms with prospective contract research organizations (“CROs”), 
 IRBs or clinical study sites;