The accompanying table of FDA decision dates is updated to include the following: 1) XenoPort (XNPT) withdrew its NDA for restless leg syndrome drug Solzira for what appears to be a minor, administrative delay to reformat some trial data at the agency's request which will also delay $23M in milestone payments from partner GlaxoSmithKline (GSK); 2) Discovery Labs (DSCO) Surfaxin NDA will undergo a Class II review with a decision deadline pushed out to 4/17/09; 3) Genentech (DNA) filed for accelerated approval of Avastin as a secondary treatment of brain cancer (glioblastoma) based on positive clinical trial results. Also, the backlog of decision dates I wrote about last week still remains -- with only DSCO hearing back from the FDA on the decision to classify Surfaxin as a Class II review, which is probably more of a reflection of the agency's understaffed conditions rather than an issue with the complete response for the drug.
$35.7 (11/13/08)
