Oramed Pharmaceuticals Inc Submits New IND Application For Oral Insulin Trial In US


Thursday, 11 Apr 2013 03:11am EDT 

Oramed Pharmaceuticals Inc announced that it has submitted a new Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for a sub-study on oral insulin candidate, ORMD-0801. This 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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