Compassionate Use Policy
At 4DMT, we are committed to developing safe, effective and transformative therapies for patients with rare diseases and limited or no treatment options. We understand the importance of bringing these therapies to the broadest group of patients as quickly as possible. We believe that the best path to potential regulatory approval, and subsequent access for the greatest number of patients, is by executing our clinical studies (or trials) as efficiently as possible. Clinical studies collect the information necessary to understand the safety and efficacy of the potential therapy allowing for regulatory review and potential approval.
After careful deliberation, we have determined that at this point in time, we must focus our efforts on conducting our clinical trials as efficiently as possible.
Therefore, participation in 4DMT clinical trials is the only way for patients to gain access to 4DMT’s investigational therapies early in development. We will continually evaluate the possibility of compassionate use, “Right to Try” and other expanded access programs.
Investigational therapies have not yet been approved by FDA or other regulatory agencies. Furthermore, investigational therapies may or may not be effective in the treatment of a condition, and use of the product may cause unexpected serious side effects.