Compassionate Use / Pre-Approval Access Policy

The team at Tyme is focused on advancing the development of SM-88 used with MPS, a therapy designed to be broadly effective across a range of tumor types.

Based on the clinical evidence from studies to date, we understand the potential that a product like SM-88 would have. We appreciate the hope that a product like SM-88 would allow an individual with cancer to seek treatment while maintaining quality of life.

While we recognize the immediate need, we must also work appropriately within the drug development system. Our product candidate is currently in clinical development and we are working with the Food and Drug Administration (FDA) to develop a clinical program that will provide Tyme with the necessary safety and efficacy data to seek marketing approval of SM-88 so that it may reach the greatest number of patients. Our goal is to conduct this clinical program rapidly yet without sacrificing the scientific rigor that the FDA requires.

We are not providing access to our investigational treatment through “compassionate use” or “pre-approval access” programs at this time. However, we will continue to reassess our policy. Please continue to check our website for information.

If you are interested in participating in a clinical trial of SM-88 used with MPS, we encourage you and your oncologist to visit our website or www.clinicaltrials.gov, where we will make a list of our studies available.