Expanded Access Policy

Vedanta and our academic collaborators are sponsoring clinical trials in the United States and internationally to carefully evaluate the safety and efficacy of several of our investigational product candidates. This is a lengthy and complex process, which includes physician investigators and their staff at clinical trial sites, regulatory authorities, and ethics committees/institutional review boards, as well as patients and their families. If the results of these clinical trials are positive, the data, along with other information, will form the basis for future regulatory applications for marketing authorization. Regulatory approval of a marketing application is required before new drugs may be made available to patients in need outside of the clinical trial setting.

We are attempting to address important, unmet medical needs with our defined bacterial consortia candidates. We realize that some patients may be interested in accessing our investigational product candidates during the investigational period and prior to regulatory approval, outside of the clinical trial setting. Such use of investigational medicines is sometimes referred to as expanded access, early access, or compassionate use. At present, Vedanta has not established an expanded access program and does not offer expanded access to our investigational product candidates outside of a clinical trial.

For more information about Vedanta’s current clinical trials, please see the overview and program-specific tabs in the Pipeline and Clinical Trials sections of this website.