>BIOD I hadn't been following them closely, but my impression had been that they were claiming the FDA was OK with the exclusion. Here's a decent discussion of the Indian data, with some links to some analyst coverage of the issue: http://seekingalpha.com/article/225291-biodel-s-linjeta-should-overcome-the-usual-fda-approval-hurdles The same author that wrote that piece also had a piece arguing that Sanofi would license the product. Peter