Wednesday, November 04, 2015 10:57:03 PM
Jan van de Winkel - President and Chief Executive Officer
Hello, Sarah. Let me probably handle all the three – just question one and three, and I’ll hand over question two to David. So subcu daratumumab is going to start, either this week or next week, so this will start very quickly. And we are enthusiastic about the subcu formulation, and the trial will be a Phase I study. It’s already visible in clinical trial and they will be followed assuming positive date by Phase III study, a large Phase III study for the subcu formulation. So we are very, very close to work with being initiated.
And then with regard to the combinations, I can tell you there is no 13 active studies with daratumumab and that numbers will more than double in the next 14 months and it will be a combination of Phase II studies if many combinations – if known drugs sell us the new agents or recently introduced agents in the landscape for the treatment of multiple myeloma, and also will contain Phase III – formal Phase III studies and depends a little bit on the combination that a young civil choose a Phase II or Phase III approach.
And certainly for Phase II studies they could be used indeed for company listings and then hopefully done to reimbursement in the United States, but it will also include formal Phase III studies. And I think over the coming months you will get further clarity on the massively expanding programs for daratumumab and that’s already indicated in the introductory remarks. Actually you’ll have a far north of presentation of daratumumab, a number of all presentations and many more poster presentation. So it will be a modest daratumumab presentation and we can’t wait to see them, Sarah, so we are very excited about that. So maybe I can hand over the second question to you David.
http://seekingalpha.com/article/3639966-genmabs-gnmsf-ceo-jan-van-de-winkel-on-q3-2015-results-earnings-call-transcript?part=single
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