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Form Type:  10-Q
Filing Date:  7/14/2014 
CIK:  0001176309 
PO BOX 39098
City, State, Zip:  JERUSALEM,  91390 
Telephone:  011 972-2-566-0001 
Fiscal Year:  08/31 
Last Trade
Last Trade: 
-0.08 (-1.05%)  
Trade Time: 
Feb 16  
Market Cap: 
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© 2018  
Description of Business
We are a pharmaceutical company currently engaged in the research and development of innovative pharmaceutical solutions, including an oral insulin capsule to be used for the treatment of individuals with diabetes, and the use of orally ingestible capsules or pills for delivery of other polypeptides. Oral insulin: We are seeking to revolutionize the treatment of diabetes through our proprietary flagship product, an orally ingestible insulin capsule, or ORMD-0801. In August 2017, we had a call with the U.S. Food and Drug Administration, or FDA, regarding ORMD-0801. During the call, the FDA advised that the regulatory pathway for the submission of ORMD-0801 would be a Biologics License Application, or BLA. Such a pathway would grant us 12 years of marketing exclusivity for ORMD-0801, if approved, and an additional six months of exclusivity may be granted to us if the product also receives approval for use in pediatric patients.