RegeneRx Biopharmaceuticals, Inc. announced that the U.S. FDA has accepted its request for a pre-BLA meeting pursuant to RGN-259, its novel product candidate for dry eye syndrome. The meeting is scheduled for February 28, 2022. A BLA (Biologics License Application) is FDA's standard full approval mechanism for biological products, including therapeutics and vaccines. The purpose of the pre-BLA meeting is to discuss with FDA the format, content, and acceptability of the anticipated BLA application. The Sponsor (ReGenTree LLC) will provide the briefing document to the agency prior to the meeting that will include a review of clinical studies, non-clinical studies, CMC (manufacturing) requirements, and previous meeting minutes between RegeneRx, ReGenTree and FDA.