Medicus Pharma CEO Dr Raza Bokhari joined Steve Darling from Proactive to discuss the company’s submission of an optimized seamless Phase 2b/3 registration-intent protocol to the U.S. Food and Drug Administration (FDA) for Teverelix®, its investigational next-generation, long-acting GnRH antagonist being developed for patients with advanced prostate cancer (APC) who are at increased cardiovascular risk. Bokhari explained that the proposed protocol is designed to establish a defined and potentially more capital-efficient pathway toward registration while positioning the Teverelix APC program for a potential strategic partnership. Importantly, Medicus does not intend to independently fund an additional clinical development study in the APC program at this time. The proposed study design is stage-gated and would begin with approximately 80 randomized patients. This initial stage is designed to incorporate and replace the previously FDA-cleared standalone 40-patient open-label Phase 2b dose-optimization study predefined continuation criteria before potentially expanding into a larger registration-intent stage. If those criteria are met, approximately 528 additional patients would be enrolled, bringing the planned total to approximately 608 participants. Medicus believes that, if accepted by the FDA, the proposed design could substantially reduce the overall size of the planned clinical development program. The company previously contemplated a program involving approximately 1,500 patients; the optimized design could reduce that figure to approximately 600 patients. The proposed pathway is intended to address several objectives within a single clinical program, including dose optimization, androgen suppression and prospective evaluation of potential cardiovascular differentiation in advanced prostate cancer patients who have elevated cardiovascular risk. Following FDA feedback, and depending on the nature of that feedback, Medicus intends to seek an out-licensing transaction or another strategic partnership for the Teverelix APC program rather than independently financing execution of the proposed registrational study. If the FDA agrees that the proposed approach could support a registration pathway, Medicus believes the design could provide a shorter and more capital-efficient route than the previously contemplated sequential clinical development program. #proactiveinvestors #nasdaq #mdcx #tsxv #mdcx #pharma #Teverelix #ProstateCancer #CancerResearch #Oncology #Biopharma #ClinicalTrials #FDA #DrugDevelopment #GnRH #AndrogenSuppression #CardiovascularRisk #Phase2 #Phase3 #ClinicalResearch #Healthcare #LifeSciences #Biotechnology