Company: MBIO
Filing Date: 2025-01-15
Form Type: S-1
Source: 0001410578-25-000028
Chunk: 39

Company: MUSTANG BIO, INC.
Filing Date: 2025-01-15
Form: S-1
Chunk 39
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ations of the Federal Food Drug and Cosmetics Act (“FDCA”) relating to the promotion of prescription drugs may lead to investigations, civil claims, and/or criminal charges alleging violations of federal and state health care fraud and abuse laws, as well as state consumer protection laws. In addition, later discovery of previously unknown adverse events or other problems with our products, manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may yield various results, including:

| ● | restrictions on such products, operations, manufacturers or manufacturing processes; |

| ● | restrictions on the labeling or marketing of a product; |

| ● | restrictions on product distribution or use; |

| ● | requirements to conduct post-marketing studies or clinical trials; |

| ● | warning letters, untitled letters, Form 483s, import alerts, and/or inspection observations; |

| ● | withdrawal of the products from the market; |

| ● | refusal to approve pending applications or supplements to approved applications that we submit; |

| ● | recall of products; |

| ● | fines, restitution or disgorgement of profits; |

| ● | suspension or withdrawal of marketing or regulatory approvals; |

| ● | suspension of any ongoing clinical trials; |

| ● | refusal to permit the import or export of our products; |

| ● | product seizure; or |

| ● | injunctions, consent decrees, and/or the imposition of civil or criminal penalties. |

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The FDA’s policies may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates, or negatively affect those products for which we may have already received regulatory approval, if any. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may be subject to the various actions listed above, including losing any marketing approval that we may have obtained. We do not know what impact any changes made by the new presidential administration will have on our business. Such actions may impact the development and commercialization of drug products and could materially harm our business and financial condition. We will need to obtain FDA approval of any proposed product brand names, and any failure or delay associated with such approval may adversely impact our business. A pharmaceutical product cannot be marketed in the U.S. or other countries until we have completed a rigorous and extensive regulatory review process, including approval of a brand name. Any brand names we intend to use for our product candidates will require approval