Oramed CEO: Oral GLP-1 analog development is rapidly proceeding
In a letter to shareholders, CEO Nadav Kidron said, "On August 31, 2017, Oramed had a call with the FDA. At this meeting, the FDA advised that the regulatory pathway for the submission of ORMD-0801 would be a Biologics License Application. Such a pathway would grant 12 years of marketing exclusivity for ORMD-0801, if approved, and an additional six months of exclusivity may be granted if the product also receives approval for use in pediatric patients. Oramed plans to initiate a 90-day treatment HbA1c trial under an FDA IND this quarter. Our oral GLP-1 analog (ORMD-0901) development is rapidly proceeding. We anticipate submitting an IND with the FDA and the initiation of a Phase II study in the United States in 2018."