Genmab — August 2016
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A request for Priority Review has been submitted by Janssen with this sBLA. The FDA will inform Janssen whether a Priority Review has been granted by calendar day 60 of their review starting today. If the FDA grants Priority Review, the review should be completed within 6 months from today.
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Forrygende! Perfekt med den nyhed ovenpå en gennemført træls periode efter Q2
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sBLA. Tager det mere end 60 dage for selve godkendelsen?
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At tage et fase et studie med er vel sjældent set eller hur? Tænk på alle de kombi der lige er startet op med Dara, ligner det sparker røv ligegyldigt hvad det kombineres med. Kursen afspejler kun faktiske kurs og indregner slet ikke forventninger, hvilket er skørt da dette antistof måske nærmest har overnaturlige evner, men nu må vi se
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Alt kører stærkt i Darzalex. Alt andet vil være uetisk
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Det er i denne sammenhæng ligegyldigt med kursstigninger. Det vigtigste er at patienterne kan få behandlingen så hurtigt som muligt.
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