Patient eligibility criteria:
- Suffer from pulmonary-recurrent osteosarcoma that has been completely resected;
- Have undergone appropriate standard treatments without success and no comparable treatment is available/exists to treat the disease;
- Are ineligible for participation in any ongoing clinical study of OST31-164 (including lack of access due to geographical constraints);
- The projected benefit of the patient’s treatment outweighs the known or anticipated risks;
- There is adequate information to support dosing for the individual patient.

Additionally, OS Therapies will consider the following when making a determination about delivery of OST31-164 under this policy:
- There is adequate supply of OST31-164 available;
- Making OST31-164 available will not negatively impact or delay the conduct of clinical trials, regulatory reviews, or approval of OST31-164 for broader patient access;
- The requesting physician is properly licensed and must agree to comply with:
- Any applicable country specific legal and regulatory requirements related to providing an investigational product under expanded access;
- Any OS Therapies requirements in terms of medical criteria, safety reporting, drug supply/use and protection of intellectual property. A treating physician may submit questions or requests regarding expanded access to OS Therapies Chief Medical and Scientific Officer, Dr. Robert Petit (rp@ostherapies.com).

It is important to note that the Expanded Access Program of OST31-164 will be discontinued if any of the below criteria are met:
- OST31-164 becomes commercially available and is therefore more broadly accessible to these patients;
- A negative regulatory decision or OS Therapies decision to discontinue development of OST31-164;
- New information becomes available about the activity or safety of OST31-164 that could substantially alter the benefit/risk profile for patients;
- Limited supply of OST31-164 or manufacturing issues.