RegeneRx Biopharmaceuticals, Inc. released an update from its U.S. joint venture, ReGenTree LLC, regarding its progress and prospects of a pre-BLA (Biologics License Application) meeting with FDA. As previously reported, ReGenTree is working with a 3rd party FDA consulting firm to complete a regulatory gap analysis and explore the prospects of a pre-BLA meeting. This includes a review of clinical studies, non-clinical studies, CMC requirements and previous meeting minutes between ReGenTree and FDA. The company plans to submit a pre-BLA meeting request to FDA within the third quarter of this year along with questions to be discussed at the meeting. According to a ReGenTree official, the gap analysis is proceeding well and the company believes there is a possibility of a pre-BLA meeting being granted based on its clinical data and regulatory package, within the targeted timeline. ReGenTree intends to officially confirm when the meeting request is granted by FDA. The purpose of a pre-BLA meeting is to discuss with FDA the format, content, and acceptability of the anticipated BLA application. If the meeting requested is granted, an applicant must provide the briefing document to the agency no later than 30 days before the scheduled date of the meeting. According to FDA's guidance regarding formal meetings, when the applicant submits a meeting request for the pre-BLA meeting, FDA may either deny the pre-BLA meeting or change it to a different type of meeting if either the provided information is premature for the stage of product development or the meeting package does not provide an adequate basis for the meeting discussion.