Cogent Biosciences’ Expanded Access Policy
Cogent Biosciences Inc. (Cogent) is a clinical-stage biotechnology company developing novel precision therapies to treat genetically defined diseases.
Expanded access is a potential option for a patient to gain access to an investigational product outside of a clinical study. In line with guidelines from the US FDA and other regulatory agencies, expanded access may be appropriate when all of the following criteria are met:
- A patient has a serious or life-threatening condition with no other satisfactory treatment options;
- There is sufficient evidence that the potential patient benefit justifies the potential risks of treatment;
- Clinical study enrollment is not possible for the patient; and
- Provision of the investigational product via expanded access will not interfere with clinical studies that could support product development and marketing approval.
Cogent believes that participation in a clinical study is the most appropriate way to access investigational therapies.
The only expanded access program available for PLX9486 is for subjects previously treated in the PLX121-01 study to enable continued treatment after study completion.
Requests can only be made by a treating physician and should be sent to email@example.com. Receipt of this request will be acknowledged within five business days.
Consistent with the 21st Century Cures Act, Cogent may revise this policy at any time.