Expanded Access Policy
Black Diamond Therapeutics is a precision oncology medicine company pioneering the discovery and development of small molecule tumor-agnostic therapies.
Expanded access, also known as compassionate use, refers to a pathway in which patients with serious or immediately life-threatening diseases or conditions may gain access to an investigational therapy outside the context of participation in clinical trials designed to evaluate safety and efficacy. The following is Black Diamond Therapeutics’ expanded access policy for evaluating and responding to requests for expanded access for individual patients.
Black Diamond Therapeutics believes that investigational therapies should be studied in patients as part of clinical trials designed to generate comprehensive safety and efficacy data that may be used to support approval of the product, which would ultimately lead to wider availability for patients. Black Diamond Therapeutics strongly encourages patients to speak with their treating physicians and, when possible, participate in clinical trials.
Black Diamond Therapeutics is aware that in certain circumstances, patients may not meet the eligibility criteria to participate in a clinical trial and may have exhausted all available treatment options. At this time, however, Black Diamond Therapeutics does not have an expanded access program that allows patients to have access to our investigational drug candidates outside enrollment in our clinical trials.
If you have any questions about our investigational drug candidates or expanded access policy, please contact Black Diamond Therapeutics at the following email address: firstname.lastname@example.org.
Timing of Acknowledgement
Black Diamond Therapeutics anticipates that it will acknowledge receipt of any questions on or requests for expanded access within five business days of receipt.
As authorized by the 21st Century Cures Act, Black Diamond Therapeutics may revise this expanded access policy at any time. Additionally, the posting of this policy by Black Diamond Therapeutics shall not serve as a guarantee of access to any specific investigational drug candidate by any individual patient.
In the United States, physicians may find additional information regarding expanded access to investigational therapies by visiting the FDA’s website, Expanded Access: Information for Physicians. Non-U.S. physicians must follow local laws and regulations appropriate for the country originating the request.
For information on Black Diamond Therapeutics’ clinical trials, including eligibility criteria for participating in ongoing studies, please visit www.clinicaltrials.gov.