NovaBridge Biosciences (NASDAQ: NBP) strives to address unmet medical needs in oncology using cutting-edge technology to fine-tune the immune network in cancers.
The U.S. Food and Drug Administration (FDA) has established criteria for the provision of investigational medicines to patients outside of clinical trials (compassionate use/expanded access). Guidance from the FDA provides that expanded access is a potential pathway for a patient when all of the following apply:
- The patient has a serious disease or condition or whose life is immediately threatened by their disease or condition.
- There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
- Patient enrollment in a clinical trial is not possible.
- Potential benefit justifies the potential risks of treatment.
- Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.
For more information about expanded access in the U.S., please visit the FDA website at https://www.fda.gov/news-events/public-health-focus/expanded-access.
Currently, NovaBridge is not accepting applications for expanded access of our investigational medicines. For patients seeking access to our investigational medicines before they are approved by a regulatory authority, participation in one of NovaBridge’s clinical trials is the most appropriate path. To learn more about available clinical trials by NovaBridge, please visit https://clinicaltrials.gov and search by company, disease or medicine.
If you have additional questions, please speak with your physician or contact info@novabridge.com.
Consistent with the 21st Century Cures Act, NovaBridge may revise this policy at any time.