Expanded Access (sometimes termed as compassionate use, early access or emergency use) refers to the use of an investigational drug outside of a clinical trial, with the primary purpose of treating a serious or immediately life-threatening disease or condition in a patient who has exhausted their treatment options and are not eligible for, or able to participate in a clinical trial. Expanded Access is different from clinical trials in that more comprehensive information about safety and effectiveness are required to be collected in clinical trials.
At this time, TME Pharma is not offering Expanded Access for NOX-A12. Access to NOX-A12-based therapies is currently available only through participation in our clinical trials which allows us to allocate available supply to study the drug’s effectiveness and safety in a controlled and evaluable setting. For more information on our clinical trials that may be recruiting new patients, please consult www.clinicaltrials.gov. We believe investigational products should be studied within the context of a clinical trial and encourage patients to enroll in a clinical trial wherever possible.