Venatorx Pharmaceuticals is focused on conducting clinical studies and obtaining regulatory approval of investigational medicines in support of its mission to develop safe and effective treatments for infectious diseases. The best way for patients to get access to investigational medicines is by taking part in clinical trials. Please search ClinicalTrials.gov for publicly available information related to Venatorx’s ongoing clinical trials.
It is recognized that not all patients are eligible to enroll in clinical trials. Venatorx will consider requests so that patients with an immediately life-threatening condition or serious disease or condition who have exhausted other appropriate treatment options may, under the conditions described below and in accordance with applicable local law, have appropriate access to its investigational medicines in development before they are commercially available. Use of an investigational product outside the scope of a clinical study is often referred to as expanded access (sometimes called compassionate use).
Expanded access is allowed in some countries under local laws and regulations and must be conducted in compliance with applicable requirements. The requirements are different across countries and the type of use that is allowed (i.e., for individual patients or groups of patients) varies.
Venatorx will consider making available, for expanded access use for individual patients, an investigational medicine in response to an unsolicited written request from a licensed physician who is in a treatment relationship with the patient/s. Expanded access requests must be sent to medinfo(at)venatorx(dot)com.
Venatorx considers the following factors when reviewing expanded access requests:
Certain expanded access and treatment studies, which involve the collection of safety and efficacy data, must be registered on ClinicalTrials.gov or other clinical trial listing website/s. The results of those studies must be made publicly available in accordance with the Venatorx standards on public disclosure.
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