...and there's an even bigger difference between doing an FDA endorsed trial in the US and doing a trial in Israel only.Their presentation reads of..."Marketing and Distribution in Specific Markets with Approved Indication Label" ....but
the only time the FDA is mentioned in their presentation is for the eventual submission of an application for their Multiple Myeloma drug for orphan disease designation.Apples and oranges really.
Ann: Ethics Approval for Phase 2 Atopic Dermatitis Study Received, page-176
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