Patients with serious or life-threatening conditions occasionally request access to investigational agents outside of a clinical trial and prior to regulatory approval and commercial availability. These patients seek such access for any number of reasons, including failure of past treatments, intolerable side effects associated with their treatment, or because they do not meet the inclusion criteria for any ongoing clinical trial for their disease.
Programs that allow for such access are known as Expanded Access Programs (EAPs) and are often also referred to as Early Access, Compassionate Use and Emergency Use.
TORL Bio is evaluating its investigational agents in clinical trials which are being conducted to meet approval requirements of the US Food and Drug Administration (FDA) and similar regulatory authorities in other countries. Due to the controlled environment and safeguards of clinical trials, TORL Bio believes this is the preferred way for patients to access its investigational medicines prior to health authority approval. Therefore, at this time TORL Bio does not offer access outside of a company sponsored clinical protocol for any of its investigational agents.
Information regarding TORL Bio’s clinical trials, as well as clinical trials and expanded access programs for other potential therapies, can be found on www.clinicaltrials.gov.
Questions regarding this Policy statement should be sent to [email protected]. If TORL Bio adopts an EAP for any of its investigational agents, this Policy Statement will be updated accordingly.