Oramed Pharmaceuticals Inc. (ORMP) announced it has submitted a new Investigational New Drug, or IND, application with the U.S. FDA for a sub-study on its oral insulin candidate, ORMD-0801.
The filing is in response to FDA feedback from Oramed's initial IND filing on December 31, 2012, wherein the FDA requested Oramed to perform a sub-study in a controlled in-patient setting for up to a one-week period prior to beginning the larger multi-centered Phase 2 trial.
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