15 Feb 2013, BioSpectrum Bureau , BioSpectrum
Singapore: Oramed Pharmaceuticals has received communication from the US FDA regarding its Investigational New Drug Application (INDA) for oral insulin. The FDA has asked Oramed to perform a sub study in a controlled in-patient setting for up to a one-week period. In order to accommodate the FDA's request, Oramed will submit a new IND with a clinical protocol for the aforementioned sub study.
Dr Nadav Kidron, CEO, Oramed, said that, "We are very pleased to be in close and positive communications with the FDA, as well as having a clear path which meets the FDA's input. This positions us for imminent clearance from the FDA to proceed with our planned clinical studies."