Why did Frost say that he thought it would take the EMA the normal 18 months to approve SQ Mabthera? The norm in Europe is 12 months. He must be expecting Roche to receive a lot of questions like with SQ Herceptin. The visibility now on both Roche targets is unclear and and his comments on HyQ were unconvincing at best. Everything else is years away. I wonder whether the bank loan is dependent on Roche approvals - I bet it is.
Frost's performance yesterday was appalling and if SQ Herceptin isn't approved in Q2 this may all get pretty ugly.
Actually, I too thought he didn't have his numbers right. On second thought, I believe, he was trying to be over-cautious with his setting expectations. 18 months would include 120 days pre-application period - which includes the appointment of the rapporteur and co-rapporteur by EMA. In the MabThera sub-Q case, this period should be much shorter, because we can expect the rapporteur/co-rapporteur to be either the original MabThera rapporteur/co-rapporteur or the same rapporteur/co-rapporteur that worked on the Herceptin sub-Q file. Also, one could argue, that once Herceptin sub-Q is approved (which we now all expect to happen in Q2'13), MabThera sub-Q is more like a line extension for which EMA has 8 months. Thus, my personal estimate is somewhere between 8 and 14 months post filing rather than 18 months. I wouldn't be surprised if we see MabThera sub-Q hitting EU-markets as early as late Q3 or Q4 2013!!