Lipocine (LPCN) shares have tumbled more than 50% after the company's New Drug Application (NDA) for lead product candidate LPCN 1021 was rejected by the FDA. In its Complete Response Letter (CRL), the FDA identified deficiencies related to the dosing algorithm for the label. Specifically, the proposed titration scheme for clinical practice was significantly different from the titration scheme used in the Phase 3 trial leading to discordance in titration decisions between the Phase 3 trial and real-world clinical practice.