Genmab — Januar 2019
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Scott Gottlieb on PDUFA - We’ll get into February but how far into Feb is still very fluid https://twitter.com/SGottliebFDA/status/1085317226150969344
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Yes. Almost the same as in Børsen E L. So we can expect them to run out of money between 3-5 weeks including this week. That will hopefully leave enough time for the approval of 1.st line Darzalex or the budget.
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Yes Solsen, but also quite a potential upside if it happens, now that we have this shutdown to take into consideration.
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Forsinkelsen er værst for patienterne.
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Lægemiddelstyrelsen var på inspektion i dag på familiens fabrik og lager i Kvanløse. Vort nye medicinlager, GDP kvalitetsstyring-system samt dokumentation bestod trykprøvningen. En stor tak til Cand. Pharm Lone Jespersen - tidligere QA hos Genmab - for bistand med skemaer og dokumenter.
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Min søn er overvågningsingeniør hos Lundbeck. Han har hjulpet mig med den digitale temperaturlogning i forbindelse med inspektionen.
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Dansk biotek og pharma har bare mange gode ansatte. Det er i højeste grad dem vi som aktionærer investerer i.
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Det gælder også Jan van de Winkel.
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God morgen
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