Tallac Therapeutics
EA Policies for Single Patient

Currently, Tallac Therapeutics does not offer an expanded access program. We believe that access to our investigational product candidates should be limited to controlled clinical trials until such time as their safety, tolerability and effectiveness have been determined and confirmed by regulatory authorities. In addition, there are regulatory constraints placed upon expanded access programs (for US guidelines see https://www.fda.gov/news-events/public-health-focus/expanded-access). Access to our product candidates before dose and dosing regimen have been optimized and safety and tolerability have been confirmed may not be in the best interests of patients.

Accordingly, while clinical trials are ongoing, we believe participation in our clinical trials is the only safe and appropriate way to access our investigational product candidates.