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Pulmocide Ltd
EA Policies for Single Patient
The goal of our current clinical study program for PC945 is to enroll patients and obtain clinical data that is required by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other regulatory authorities for review and approval of marketing applications for this investigational agent. We believe that focusing on clinical studies is the most appropriate way to achieve this goal; therefore, we do not currently offer access to PC945 outside of clinical studies and, at this time have no Expanded Access program (sometimes referred to as “compassionate use” or “pre-approval access”).