huge - approval was a virtual slam dunk if you took him at his word a month or so ago
with the CFO having given guidance for Q1 on an ANDA which has no PDUFA date the possibility that TEVA heard back about immunogenicity and were merely awaiting final approval crossed my mind. that worst case scenario is now off the table. the more bullish revelation imo - since most of us still assumed immunogenicity was still unresolved - was that there could be a "more complicated answer". this really tells me there is more than immunogenicity still unresolved.