02 August 2013 | Regulatory | By BioSpectrum Bureau
Oramed submits pre-IND meeting request to FDA for its oral exenatide capsule ORMD-0901
Singapore: Oramed Pharmaceuticals, a developer of oral drug delivery systems, submitted a pre-Investigational New Drug (pre-IND) meeting request to the US FDA for a US-based trial on its orally ingestible exenatide capsule, ORMD-0901.
Mr Nadav Kidron, CEO, Oramed, commented that, "We are very pleased to have submitted this pre-IND meeting request letter as part of our efforts to advance ORMD-0901 into US clinical trials. We look forward to the FDA's response and preparing ourselves accordingly in our efforts leading up to full IND submission on our second product."