Genmab — Februar 2019
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Det er ved at være 3 uger siden vi fik RTOR meddelelsen - det kunne være forrygende med en af de gode gamle fredagsnyheder efter luk!!!
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Åh nej..Den slags gjorte det så svært for mig at komme på arbejde lørdag morgen.
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Du er sikker på, at det ikke var den resulterende rødvin, der skabte problemerne?
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where do you think we are on that RTOR timeline? i saw earlier in this onclive article "Janssen and Genmab have completed the first part of a supplemental biologics license application for daratumumab …." https://www.onclive.com/web-exclusives/fda-approves-splitdosing-regimen-of-daratumumab-for-multiple-myeloma?p=2
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According to the timeline first submission takes place 6-9 weeks after top line. That was 3 weeks ago. Lets say week 12 now then. Which means another 4 weeks to last submission. And then another 4 weeks until decision. This is maximum. Could be shorter.
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Der er lidt baggrund omkring de forskellige godkendelsesprocessen her - https://www.focr.org/sites/default/files/pdf/ROTR White Paper 1.pdf
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Se specielt side 8 med diagrammer for kisqali og Keytruda rtor processer
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Men det ser også ud til at fda strammer processen til fra 2018 til 2019, så det bliver noget mere smooth
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