Company: REVB
Filing Date: 2025-04-04
Form Type: DRS
Source: 0001213900-25-029022
Chunk: 120

Company: REVELATION BIOSCIENCES, INC.
Filing Date: 2025-04-04
Form: DRS
Chunk 120
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bursement may impact the demand for, or the price of, any product for which we obtain regulatory approval. 76 Third -partypayors are increasingly challenging the price, examining the medical necessity, and reviewing the cost -effectivenessof medical products, therapies, and services, in addition to questioning their safety and efficacy. Obtaining reimbursement for our products may be particularly difficult because of the higher prices often associated with branded drugs and drugs administered under the supervision of a physician. We may need to conduct expensive pharmacoeconomic studies in order to demonstrate the medical necessity and cost -effectivenessof our products, in addition to the costs required to obtain FDA approvals. Our product candidates may not be considered medically necessary or cost -effective. Obtaining coverage and reimbursement approval of a product from a government or other third -partypayor is a time -consumingand costly process that could require us to provide to each payor supporting scientific, clinical and cost -effectivenessdata for the use of our product on a payor -by -payorbasis, with no assurance that coverage and adequate reimbursement will be obtained. A payor’s decision to provide coverage for a product does not imply that an adequate reimbursement rate will be approved. Further, one payor’s determination to provide coverage for a product does not assure that other payors will also provide coverage for the product. Adequate third -partyreimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate return on our investment in product development. If reimbursement is not available or is available only at limited levels, we may not be able to successfully commercialize any product candidate that we successfully develop. Different pricing and reimbursement schemes exist in other countries. In the European Union, governments influence the price of pharmaceutical products through their pricing and reimbursement rules and control of national health care systems that fund a large part of the cost of those products to consumers. Some jurisdictions operate positive and negative list systems under which products may only be marketed once a reimbursement price has been agreed. To obtain reimbursement or pricing approval, some of these countries may require the completion of clinical studies that compare the cost effectiveness of a particular product candidate to currently available therapies. Other member states allow companies to fix their own prices for medicines but monitor and control company profits. The downward pressure on health care costs has become intense. As a result, increasingly high barriers are being erected to the entry of new products. In addition, in some countries, cross -borderimports from low -pricedmarkets exert a commercial pressure on pricing