PHV is a biotechnology company developing products for the prevention and control of global emerging infectious diseases. Our investigational products are for serious, life-threatening diseases for which there are no or limited interventions. They are under evaluation. PHV’s product development process includes human clinical trials to assess safety and effectiveness of these investigational products in the diseases they are intended to prevent and/or control. These regulated clinical trials are conducted to support eventual marketing applications with the US Food and Drug Administration and National Regulatory Authorities which would allow for distribution and use.
Under the 21st Century Cures Act (“Act”), expanded access to investigational products for serious or life-threatening disease may be made available outside of formal clinical trials and under certain conditions. As manufacturers advance to certain stages in product development, they are obligated to publicly share their Expanded Access Policy.
PHV recommends access to its investigational products through its clinical trials which generate the data to support marketing registration. After careful consideration, at this time, we are not able to grant expanded access (sometimes referred to as compassionate use) as there is insufficient information to allow patients and physicians to adequately assess the risks and benefits associated with these investigational drugs when used outside of the confines of a controlled clinical trial. For more information on PHV’s ongoing clinical trials, see www.clinicaltrials.gov.
Under the Act, PHV may revise this policy at any time and updates will be made available on this website.