Successful End of Ph 2 Meeting with US FDA on Ph 3 Registrational Study Design for PT-112 in Patients with Metastatic CRPC Announced
“Consistent with FDA Project Optimus, the FDA agreed with the proposed dosing regimen for use in a prospective, randomized controlled Phase 3 registrational study, on the basis of the completed Phase 2 clinical trial. The study design and endpoints, along with the proposed comparator and statistical framework, were agreed in principle, as were Promontory’s proposed patient population within mCRPC, and proposal for an interim analysis. The latter would allow a potential pathway for drug approval prior to the full completion of the Phase 3 study.”
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