TopAlliance Biosciences, Inc. is committed to the development of innovative therapies for patients in the communities we serve, including our employees, and to preserve the environment we operate in. We believe in remaining true to the inspirations that have driven the success of our company and will continue to let science and pragmatism drive our objectives in finding cures for patients.
“Expanded Access” refers to the use of an investigational product outside of a clinical trial for potential treatment of patients. The US Food and Drug Administration has set forth criteria for when use of an investigational drug is permitted under the provisions of expanded access. They include all of the following:
TopAlliance Biosciences, Inc. is committed to the development of innovative therapies for patients in the communities we serve, including our employees, and to preserve the environment we operate in. We believe in remaining true to the inspirations that have driven the success of our company and will continue to let science and pragmatism drive our objectives in finding cures for patients.
“Expanded Access” refers to the use of an investigational product outside of a clinical trial for potential treatment of patients. The US Food and Drug Administration has set forth criteria for when use of an investigational drug is permitted under the provisions of expanded access. They include all of the following:
- A disease or condition that is serious or life-threatening with no satisfactory treatment options (such as approved products or enrolling clinical trials)
- There is sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks, based on available safety and efficacy information
- Whether granting expanded access would potentially compromise the scientific validity of broader development programs or interfere with or delay current clinical trials or regulatory filings designed to make the therapy available to many more patients.
Based on current resources, TopAlliance is not currently making its investigational products available for use under expanded access programs.
If this policy changes, TopAlliance will provide additional information on the scope of the expanded access program and procedures we intend to follow.
You may reference information about our pipeline and ongoing clinical trials by accessing http://www.topalliancebio.com/ or https://www.clinicaltrials.gov.
