I've read just about all there is to read but can't find any info as to when European regulators will render a decision on roche's application to market Herceptin SC. Does anyone know the answer? Also, I'm wondering why a comparable application wasn't filed with the FDA.
EMA: Approval due about one year post filing
FDA: There is no attractive s.c. market in the US. Oncologists pocket so many more $$$ per i.v. injection. Genentech chose not to file an application, it appears.
considering the relatively low royalty rate, it doesn't sound like this particular indication is going to be a huge revenue generator for HALO. sounds like if EMA rejects, the stock gets hammered, and if approved, not that huge a deal. Any thoughts? i'm thinking about doing a straddle before the EMA decision.