At this time, Tachyon Therapeutics does not have any investigational drug candidates available for expanded access anywhere in the world since they are in early stages of development. Tachyon will evaluate the potential for expanded access on an ongoing basis utilizing all available clinical data to determine a risk/benefit profile of the candidate. This policy will be re-assessed on an annual basis, at a minimum, during the preparation of the IND Annual Report.
When and if Tachyon decides to make its investigational product(s) available through an Expanded Access Program (EAP), Tachyon will evaluate and respond to each request on a case-by-case basis using criteria that ensures each request is considered in a fair and consistent manner, and in compliance with Regulatory requirements. At that time, this policy will be updated with detailed information so that a patient’s physician can request access.
If there is interest to participate in a clinical trial with a Tachyon investigational drug candidate, relevant information on study(s) available to patients can be found on clinicaltrials.gov.
The posting of this policy on the Tachyon website is consistent with the 21st Century Cures Act.