Company: BIAF
Filing Date: 2025-04-15
Form Type: DRS
Source: 0001641172-25-004915
Chunk: 66

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-15
Form: DRS
Chunk 66
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 product candidates outweigh any safety or other        
 perceived risks;                                                                                                                  |
| ● | the                                                                                                                               
 FDA’s determination that additional preclinical or clinical trials are required;                                                  |
| ● | the                                                                                                                               
 FDA’s non-approval of the formulation, labeling, or specifications of our product candidates;                                     |
| ● | the                                                                                                                               
 FDA’s failure to accept the manufacturing processes, drug product characteristics, or facilities of third-party manufacturers     
 with which we or the third-party licensors contract; or                                                                           |
| ● | the                                                                                                                               
 potential for approval policies or regulations of the FDA to significantly change in a manner rendering clinical data related to  
 any therapeutic product candidate insufficient for approval.                                                                      |

Even if clinical testing approval of any regulatory filing for our product candidates eventually is completed, the FDA may grant approval contingent on the performance of costly additional post-approval clinical trials. The FDA may also approve our product candidates for a more limited indication or a narrower patient population than the third party originally requested, and the FDA may not approve the labeling that we believe is necessary or desirable for the successful commercialization of our product candidates. If the FDA requires the licensors to narrow the indications to smaller patient subsets, the market opportunities for our product candidates, if approved, and the ability to generate revenues and royalties may be materially limited. To the extent the licensors seeks regulatory approval in foreign countries, they may face challenges similar to those described above with regulatory authorities in applicable jurisdictions.

| 29 |

Obtaining and maintaining regulatory approval of our diagnostic tests or therapeutic product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions. Failure to obtain regulatory approval in foreign jurisdictions would prevent our product candidates from being marketed abroad.

In addition to regulations in the U.S., to market and sell our diagnostic tests and therapeutic products in the EU, many Asian countries, and other jurisdictions, we must obtain separate regulatory approvals and comply with numerous and varying regulatory requirements, both from a clinical and manufacturing perspective. Clearance by the FDA does not ensure approval by regulatory or payor authorities in other countries or jurisdictions, and approval by one regulatory or payor authority outside the U.S. does not ensure approval by regulatory authorities in other countries or jurisdictions or by the FDA. However, a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory approval process in others. For example, even if the FDA grants marketing authorization of a diagnostic test or therapeutic product candidate, comparable regulatory authorities in foreign jurisdictions must also approve