At Reven, we realize how important it is for people to seek access to investigational medicines before they are reviewed and approved by a regulatory body such as the FDA. We continue to encourage patients to access and participate in clinical trials. However, when patients have exhausted all avenues for medicinal options, Reven may consider providing an investigational medicine outside of a clinical trial. This is known as expanded access.
Our Approach
If eligible and available due to sufficient clinical information, Reven may offer Group or Individual Patient Expanded Access for serious or life-threatening conditions where the investigational medicine sufficiently is qualified for a population of patients where it may be deemed appropriate. This is completed through our specific protocols in conjunction with regulatory agency consultations for the use of the investigational medicine where it is permitted.
Reven’s initiative to shift paradigms with first-in-class multimodal drug development and research gains strength with collaboration. Reven’s biotech movement continues to gain traction as a result of collaborations with incredible partners.