Neoprobe sold a device called neoprobe to Devicor Medical Products earlier in 2011, so the company's management decided that it was a good time to rebrand the company as a precision diagnostics-focused biotech company that developed products like Lymphoseek. We were initially expecting an FDA approval for Lymphoseek on June 10, 2012 based on the timing of Navidea's NDA submission for Lymphoseek, but we saw a 3-month delay announced in April that brought the PDUFA action date to September 10th, 2012. This was because the FDA wanted some extra time to review the Chemical, Manufacturing, and Control (CMC) information that they required Navidea to submit (which they did on March 30th, 2012). The market (and the company) was unsure just how concerned the FDA was about the third-party manufacturing process that Lymphoseek underwent, but it's now apparent that the FDA saw some serious safety concerns in Navidea's. report.