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Reply To: EAP PatientsNovember 6, 2019 at 6:23 pm
No, expanded access trials can enroll new patients that meet the criteria set out in the expanded access protocol.
(Note: Companies are not required to set up an EA protocol (new study) at the conclusion of a clinical study. Another strategy to continue to supply patients from a clinical study is to amend the existing clinical protocol to allow patients to continue.)
With Kind Regards,
GCSG Expanded Access Resource Group