Genmab — Juni 2019
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Thanks, Peter, for the questions. So I will pass on the second one to David and then answer the first one myself. Strictly, there is only one noninferiority Phase III study needed, Peter, to get the label, potential label for the subcu formulation, but that's only in the refractory multiple myeloma population
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Janssen intends to actually ask for a very broad label for all the potential indications. So one needs indeed also the data from the PLEIADES study, an over 180-patient Phase II study. Janssen has that data. That data will be presented, I think, soon also at a conference. And that together, that data will be filed together with the COLUMBA data in both U.S. and Europe in the summer time frame.
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The exact timing is not clear to me, but that is the timing I've heard from our partner, Peter. So they need both of the studies to get a broad label for the subcutaneous formulation. What I understand is if things go well, go very well, what we hope to see is indeed the full color of the COLUMBA data at the ASCO conference, potentially also at EHA a few weeks later. And I think they will also present the PLEIADES data at some point, but it seems to be in good shape.
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Personligt bryder jeg mig ikke ret meget om, at der foregår et eller andet bag vores ryg - altså med Nasdaq listing og investor presentationer vi ikke får del i ! Det virker bestemt som om der foregår noget som pøblen ikke skal have nys om, før de tunge drenge er blevet enige
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Ergo kan det betyde at vi ikke når 3 milliarder i år og derved misser den store milestone på 150 miilioner dollars - helt slemt vil det være, hvis vi ikke en gang rammer 2,5 milliarder dollars og får den lidt mindre på 100 millioner dollars - det tror jeg dog ikke, for så skal salget gå helt i stå.
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Hvis MAIA ikke er godt nok til SOC, så vil det også få afsmittende effekt de kommende år - formentlig også selv om sc dosering går igennem. Vi mangler stadig at se data fra PLEIADES - det er her den store værdi ligger. Forstår ikke helt at Janssen har data, når der lige er tilføjet en ny arm (måske Jan ikke er helt informeret).
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Jeg kan sagtens følge dig Sukkeralf 10:07. Jan plejer jo gerne at ville fortælle vidt og bredt om selskabets fremskridt med mindre han båndlægges af Jansen. Så der foregår tydeligvis noget, som vi ikke skal vide noget om pt. Hvis der skulle være tale om dårligt nyt skulle det vel være oplyst via en børsmeddelelse, så den heller jeg ikke til.
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Ja hvis der er noget dårligt i sigte har de jo en forpligtelse til at meddele det. Al andet vil betyde søgsmål som det vi f.eks. så mod Vestas.
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poster on MAIA QoL
https://twitter.com/AuclairDan/status/1135626749260312576
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