Genmab — Juni 2020
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Ups
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Genmab: FDA forlænger godkendelsesproces
De amerikanske sundhedsmyndigheder, Food and Drug Administration (FDA), har forlænget godkendelsesprocessen for Ofatumumab til behandling af patienter med multipel sklerose med tilbagefald, RMS.Det op
borsen.dk (borsen.dk)
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Det er nok årsagen til den svage kursudvikling i dag
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Det må det være.
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Alt andet lige bør det ikke påvirke kursen.
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Fred være med det.
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Men hvorfor nogen bliver usikket på partnerdeal netop i dag, foretår jeg ikke. Jan bekræftede jo timingen endnu engang hos Jefferies
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Fra Novartis pressemedd: "Basel, June 2, 2020 — Novartis today announced that it has received notice from the US Food and Drug Administration (FDA) that the agency has extended its review of the Supplemental Biologics License Application (sBLA) for ofatumumab (OMB 157), a self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis. Regulatory action is now expected in September 2020."
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Vi er jo stadig i 2. kvartal...
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Jan bekræftede timing i dag, så jeg er optimist...
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Novartis opkyste i februar forventet godkendelse i juni, så det ligner en forlængelse på tre måneder https://www.novartis.com/news/media-releases/novartis-announces-fda-and-ema-filing-acceptance-ofatumumab-novel-b-cell-therapy-patients-relapsing-forms-multiple-sclerosis-rms
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