Doron Therapeutics’ goal, whenever possible, is to encourage patients to participate in our clinical trials. Clinical trials determine how well an investigational therapy, like PTP-001, works as compared to the existing standard of care or a placebo, and whether the potential therapy is safe and effective. Clinical trials also explore whether the benefits of the investigational therapy outweigh the risks and provide the safest opportunity for people to access an investigational therapy before it is approved by a regulatory agency.

Under Section 561A(f)(2) of the US Federal Food, Drug, and Cosmetic Act (FDCA) Doron is also required to make its Expanded Access Policy for PTP-001 publicly available. At this point in time, PTP-001 is not available for Expanded Access Use. Doron Therapeutics will re-evaluate its Expanded Access Policy on a periodic basis and make any updates publicly available.
If Doron Therapeutics decides to make PTP-001 available for Expanded Access Use, we will evaluate and respond to each request that we receive from a patient’s treating physician on a case-by-case basis. Questions about Doron’s Expanded Access Policy should be made by email to [email protected].