Tourmaline Bio, Inc. Expanded Access Policy
Tourmaline is committed to developing transformative medicines that dramatically improve the lives of patients with life-altering immune diseases. Our goal is to provide access to our medicines at the appropriate time and in a manner that is most beneficial to the relevant patient population. We believe that focusing on the initiation and conduct of clinical trials is the safest and most effective way to achieve this goal.
Tourmaline understands that some patients may wish to access our medicines before results of a clinical trial are available or a product is approved by the FDA, or they may not meet the eligibility criteria for an available clinical trial. Tourmaline recognizes the potential need for Expanded Access Programs for these patients.
At this time, an Expanded Access Program is not available for TOUR006. Tourmaline will re-evaluate the status of this policy on a regular basis.
An Expanded Access Program for TOUR006 may be opened once Tourmaline determines that all of the following eligibility requirements and criteria are met:
- The investigational drug is the subject of an active clinical development program.
- The investigational drug is intended to treat patients who suffer from a serious or immediately life-threatening disease or condition who lack satisfactory therapeutic alternatives.
- An adequate supply of the investigational drug exists to perform necessary clinical studies as well as to provide expanded access to patients who do not have alternative treatment options.
- Expanded access will not impede or compromise the initiation, conduct or completion of clinical trials in a timely fashion.
- Expanded access will not delay regulatory approval and availability of the investigational drug to a broad patient population.
- Sufficient scientific evidence demonstrates that the possible benefits of the investigational drug outweigh the possible risks to the patient and that such risks are not unreasonable given the disease or condition to be treated.
We encourage patients who are interested in learning about our clinical trials to consult their healthcare provider and/or visit clinicaltrials.gov and search for Tourmaline Bio.