I had always assumed a trial drug could only be used in combo with an approved drug, but I thought I had heard they don't need to wait for FDA approval to start an OnCARlytics + Azer-Cel trial - I could be wrong. Imugene plan on filing an IND and getting the trial set up next year anyway.
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Ann: Phase 1 onCARlytics Trial Advances to Combination Arm, page-42
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