I talked to the CDER Ombudsman on the phone. She spoke to CDER at my request. NCE happens to be a "legal issue with CDER" she obviously wouldn't move beyond that. She did have a strange silence when asked if the OB Patents where the possible legal barrier. With this info in addition to the NIH pharm update article, I expect NCE will be granted and announced in the October supplemental.
885 patent is a composition patent--very important patent for defending against Generics sale in USA.
Remember-Ranbaxy tried to get FDA approval and tried to sell Generic in USA.They lost in patents court. Finally they started selling after patents expired.
PATENTS are important in longterm--not NCE for 5 years.
NCE for 5 years vs, 3 years--only saves 5-6 million$ in legal fees in defending their patents. US Patents courts are VERY TOUGH.