Core Viewpoint - INmune Bio has submitted a pre-submission package for CORDStrom to the UK's Medicines and Healthcare Products Regulatory Agency, aiming to expedite the Marketing Authorization Application process for a potential systemic therapy for a severe skin disease [1] Group 1: Regulatory Engagement - The pre-submission package is intended to gather targeted scientific, regulatory, and procedural feedback, which may streamline the full Marketing Authorization Application process [1] - The company plans to file a full Marketing Authorization Application with MHRA after receiving pre-submission feedback, expected by mid-summer 2026 [1] Group 2: Manufacturing Readiness - INmune Bio has completed three commercial pilot-scale manufacturing runs at the CGT Catapult facility, demonstrating consistent product characteristics that met predefined release criteria [1] - These manufacturing results confirm the company's readiness for commercial supply [1] Group 3: Future Regulatory Submissions - Following the MHRA submission, the company anticipates subsequent regulatory submissions in the EU and U.S. in Q4 2026, contingent on regulatory alignment and manufacturing readiness [1]