About the 505(b)(2) Regulatory Pathway

Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act is intended to streamline the development and U.S. Food and Drug Administration (FDA) approval of pharmaceutical products that incorporate already-approved pharmacological agents. This provision was meant to encourage innovation and reduce the amount of duplicative research required for the approval of a clinically significant improvement to a well-characterized chemical entity. The 505(b)(2) regulatory pathway provides for FDA approval of a drug based in part on data that was not developed by the sponsor of the application, including published literature references and data previously reviewed by the FDA for the approval of a separate application. The scope of data from a prior application that can be referenced by a new sponsor is determined with FDA input and can include part of the required preclinical or clinical studies for approval. As our focus is on applying our technologies to already-approved pharmacological agents, we seek to leverage this pathway to potentially accelerate the development and lower the clinical and regulatory risk of our product candidates.