aossa schreef:
Q&A:
And finally, your question relating to production and you mentioned Crucell, so I assume here we are talking about the therapeutic side of the business, which is where our relationship with Crucell and DSM is.
Thomas Schießle: Yes.
Simon Moroney: As you know, we are producing both MOR103 and MOR202 with DSM using Crucell's PER.C6 cell line. The production of material for the clinical trials in both of those programs is ongoing and on track as planned. It actually is available at DSM, to achieve what we need, and therefore there is no change in infrastructural capacity in order to meet the needs that we have. We can achieve that through working with DSM.
George Zavoico: All right. And regarding MOR103, the Phase 1b/2a clinical presentations with RA, is it too early to provide some details to how you plan to go about performing that trial, conducting that trial and how long it might take?
Simon Moroney: We will provide that information. We are actually just at the moment waiting for the feedback to our clinical trial applications from the European authorities here because of course there maybe questions; we may need to provide answers and so on. And until that's taken place, we're just kind of holding back on providing that information. But we fully intend to be transparent about the trial design besides the number of patients and so on and so forth, and we hope to be able to provide that information within the next weeks to a couple of months, perhaps.
Elmar Kraus, DZ Bank: Hello, everybody good afternoon. And I've got two questions that they actually fit nicely together to the questions that we just had. One was, Simon, you said you haven't got an answer yet on your clinical trial application for MOR103. And I would at least expect that you got the conformation that everything went in there in place, and that everything was complete and that they start to review now. So perhaps you can clarify that for me.
And the other one is when we are looking at the current EUR8.5 million of proprietary drug development, and this is without major let's say clinical trials that you are expecting for MOR103. How do you think this will actually go on over the next quarters to actually reach, and not to exceed your guidance of expenses for clinical trials of the proprietary drug development? Because obviously with clinical trials and patients it gets substantially more expensive. Thanks.
Simon Moroney: Yes. Elmar, thanks for that. Of course, I should have made clear that we have indeed got the acknowledgement from the regulatory authorities regarding the submission of the clinical trial application. What we're waiting for is the response in terms of confirmation that we can proceed or perhaps more questions. So the acknowledgement has indeed been received as we expected on the schedule that we expected. And to go back to the second part of your question regarding the cost for drug development, we guided at the beginning of the year to proprietary development costs of EUR18 million to EUR20 million. As you had seen, we haven't quite spent half of that through the first six months of the year, but we absolutely expect to fall into that 18 to 20 range through the end of the year.
So we obviously have a detail plan for all of our proprietary development activities and that plan we are keeping to and the cost for expenditure is somewhere in the range of 18 to 20 and we could expect to lie on that range by year end.
Elmar Kraus: Thank you for that clarification.
www.morphosys.com/uploads/MOR090728_Q...