Upcoming Milestones per report. A potential RIGS partner can be added as well.
- 1H12– Potential for interim data from NEO3-06 Lymphoseek Phase III Trial - 1H12 – Progress on EU/RoW Lymphoseek distribution partnerships - June 30th, 2012– Potential licensing of [123I]-E-IACFT from Alseres - September 10th, 2012– Lymphoseek PDUFA date - 2H12 – Filing of Lymphoseek MAA with EMA - 2H12 – Initiation of additional Phase II studies for AZD4694 - 2012– Re-initiate human clinical studies of RIGScan - Early 2013– Initiate Phase III clinical program for AZD4694 - 2013 – Potential MAA approval for Lymphoseek
"In fact, if the agency had been leaning towards rejecting the application, we believe that the original PDUFA date of June 10 would have been maintained and the agency would have issued a complete response letter rejecting the drug outright. Therefore, we believe this is arguably good news as the Agency wants to ensure ample time to review the application and the FDA-requested documents that were recently submitted."