Genmab — Februar 2019
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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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men vi skal vel se en full submission, før vi kommer til at se en evt. godkendelse
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anyway - full submission må være lige op over, som du siger. Hvis vi kan få 3 hele kvartalers US salg, vil jeg være glad
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I øvrigt, så må JJ også være igang med ansøgning i EU
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jeg tænkte på indsendelse af Maia I EU - normalt tager ansøgningerne rundt regnet lige lang tid. Behandlingen er så en anden sag..
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