Company: REVB
Filing Date: 2025-05-20
Form Type: S-1
Source: 0001213900-25-045828
Chunk: 28

Company: REVELATION BIOSCIENCES, INC.
Filing Date: 2025-05-20
Form: S-1
Chunk 28
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 the FDA or other regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Even if we obtain regulatory approval for a product candidate, our products and business will remain subject to ongoing regulatory obligations and review. Even if our Program Products are approved, they will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, distribution, promotion, sampling, record-keeping, conduct of post-marketing studies and submission of safety, efficacy and other post-market information, including both federal and state requirements in the United States and comparable requirements outside of the United States. Accordingly, we and others with whom we work must continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production and quality control. If a regulatory agency discovers previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, quality of product or disagrees with the promotion, marketing or labeling of a product, such regulatory agency may impose restrictions on that product or us, including requiring recall or withdrawal of the product from the market. 15 In addition, manufacturers of drug products and their facilities are subject to continual review and periodic inspections by the FDA and other regulatory authorities for compliance with cGMP, regulations and standards. If we or a regulatory agency discover previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured, a regulatory agency may impose restrictions on that product, the manufacturing facility or us, including requiring recall or withdrawal of the product from the market or suspension of manufacturing. If we, our product candidates or the manufacturing facilities for our product candidates fail to comply with applicable regulatory requirements, or undesirable side effects caused by such products are identified, a regulatory agency may:

| ● | issue safety alerts, Dear Healthcare Provider letters, press             
 releases or other communications containing warnings about such product; |

| ● | mandate modification to promotional materials or require          
 us to provide corrective information to healthcare practitioners; |

| ● | require that we conduct post-marketing studies; |

| ● | require us to enter into a consent decree, which can include                                                                              
 imposition of various fines, reimbursements for inspection costs, required due dates for specific action and penalties for noncompliance; |

| ● | seek an injunction or impose civil or criminal penalties 
 or monetary fines;                                       |

| ● | suspend marketing of, withdraw regulatory approval of or 
 recall such product;                                     |

| ● | suspend any ongoing clinical studies