Expanded Access Policy
BioMimetix is a clinical-stage biotechnology company and we are committed to developing our novel metalloporphyrin, BMX-001 for the purposes of improving the lives of patients with several types of cancers, in a manner most appropriate for the patients. Our current emphasis is on completing our ongoing clinical trials to demonstrate safety and efficacy in order to obtain the necessary regulatory approval and provide widespread accessibility of this drug.
Before a drug has been approved by a regulatory authority, such as the US Food and Drug Administration (FDA), patients need to participate in a clinical trial to gain access to investigational treatments, such as BMX-001. There is a program called Expanded access or compassionate use, which enables patients with some serious or life-threatening diseases to gain access to investigational treatments outside of the clinical trial. Currently, BioMimetix does not offer an expanded access program, and does not accept requests for expanded access. Allowing access to patients outside of a controlled clinical trial may interfere with the conduct of our ongoing programs and the progress of our development program.
At this time, we believe that access to BMX-001 should be limited to controlled clinical trials, and you may visit this link for more information about our clinical trials.
If you have questions about BioMimetix’s expanded access policy, please contact us at email@example.com.
Consistent with the 21st Century Cures Act, BioMimetix may revise this policy at any time.