Genmab — August 2018
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Det er altså forkert at prøve at hænge MAIA op på en bestemt datoknag. Stockbull - han “refereres” til at sige: “under forudsætning af, at data kommer i august-september”. Det er ikke en præcisering, og tror aldrig han har ment at man kunne præcisere det. Mon ikke vi i stedet blot skal håbe at det er positivt at MAIA trækker ud (og ikke det modsatte) - hvis det overhovedet er trukket ud.
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Jeg tænker heller ikke, der er grund til urolighed omkring Maia - ud over selvfølgelig den ekstreme vigtighed studiet har for GEN...
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Vi skulle jo gerne - lige som med Alcyone - derhen at de lukker studiet af humanitære årsager og folder kontrolarmen ind
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når du siger det på den måde, så er jeg da ikke sikker - checker lige...
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næh - du har ret. Ikke noget stop på kontrolarmen, men fortsat monitoring: http://ir.genmab.com/news-releases/news-release-details/genmab-announces-positive-topline-results-phase-iii-alcyone
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Rachel Gravesen sidste år på forespørgsel: "The IDMC have yet to take the formal decision on what to do regarding the control group patients and whether they should be offered daratumumab. I would expect this to be something that is considered very soon and a decision taken and verified through the necessary channels." forts
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The Alcyone study continues in terms of patients that are in the dara arm may still be having a response and therefore would continue in the study but the data is unblinded so the data from yesterday is the data that will be used as a basis for discussions with regulatory authorities for a potential submission to include Dara + VMP in the DARZALEX label.
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nej - I hvert fald ikke efterfølgende. Men det er jo også precious little vi har hørt fra det studie efterfølgende
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