[Gretchen Randlett]

Reply To: EAP from Open label studies

Regardless of the type of trial, e.g. open-label, you should not transition the patients to expanded access. It is recommended that you continue to provide those patient in the trail access to therapy by continuing the open-label study or amending the study to accommodate them under continued access.

The Expanded Access mechanism ( also known as compassionate use) should only be used when a patient cannot participate in clinical trial and there is no other treatment options available for that patient. The Expanded Access mechanism, stops when the drug is commercial available and reimbursable in the specific country.