Expanded Access Intelligence

No evidence found.

Reagan-Udall Foundation Insights

Company
Pulmocide
Additional Information

Single-Patient EA Policies/Criteria 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”).

Partner with Right2Hope

Right2Hope helps sponsors translate regulatory programs into actionable patient access pathways. Connect with our team to publish new programs, streamline intake workflows, or align with providers seeking compassionate use options.