Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 121

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 121
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 before a patent is issued, and its scope can be reinterpreted and even challenged
after issuance. As a result, we cannot guarantee that any of our product candidates will be protectable or remain protected by enforceable
patents. We cannot predict whether the patent applications we are currently pursuing will issue as patents in any particular jurisdiction
or whether the claims of any issued patents will provide sufficient proprietary protection from competitors. Any patents that we hold
may be challenged, circumvented or invalidated by third parties.

<div align='center'>74

Regulation</div>

Government Regulation

Government authorities at the federal, state
and local level in the United States and in other countries and jurisdictions, including UK, EU and chosen APAC countries, extensively
regulate, among other things, the research, development, testing, manufacture, pricing, reimbursement, sales, quality control, approval,
packaging, storage, recordkeeping, labeling, advertising, promotion, distribution, marketing, post-approval monitoring and reporting
and import and export of pharmaceutical products such as those we are developing.

We, along with our CMOs, CROs and third-party
vendors, will be required to satisfy these requirements in each of the countries in which we wish to conduct studies or seek approval
or licensure of our product candidates. The processes for obtaining marketing approvals in the United States and in foreign countries
and jurisdictions, along with subsequent compliance with applicable statutes, regulations, and other regulatory requirements, require
the expenditure of substantial time and financial resources.

Licensure and Regulation of Pharmaceutical Products in the United States

Licensure and Regulation of Pharmaceutical Products in the United
States

We are currently developing product candidates
that are regulated as pharmaceutical (drug) products. In the United States, the development, approval, and commercialization of pharmaceutical
products are governed primarily by the Federal Food, Drug, and Cosmetic Act (FDCA) and related regulations enforced by the U.S. Food
and Drug Administration (FDA). Drug development programs may ultimately proceed toward one of two primary FDA approval pathways under
the Food, Drug, and Cosmetic Act: Section 505(b)(1) or Section 505(b)(2). A 505(b)(1) application is used for new drugs with full reports
of safety and efficacy data from studies conducted by the applicant. In contrast, a 505(b)(2) application allows the sponsor to rely
in part on data not developed by them, such as published literature or data from an already approved drug, while