Genmab — August 2015
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The often cited 8.5-month improvement is an illusion: treatmentarm
survival was unexceptional relative to the results of other trials in similar patient
populations, while placebo-arm survival was anomalously poor. This strikingly bad placebo
performance likely had several causes, but one important one was age: relative to men who
received Prostvac, those who received a placebo were much older – indeed, older than any
group we have come across in any prostate-cancer clinical trial. -
Jeg har heller ikke selv ønsket at være med - svært at vurdere. Desuden falder fase III data ofte dårligere ud end fase II. Cancervacciner ligger ligeledes helt i bunden. Sidst men ikke mindst har BMS i første omgang også valgt en option på Prostvac og afventer derfor fase III data før yderligere betaling.
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"De onde hedgefonde mod Bavarian": http://www.proinvestor.com/debat/72848
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Det vil ikke være ikke være dårligt.
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Og hvad med denne her Royal, den kan komme om max 4 dage: Offentliggjort 09.07.15 kl. 19:50 Janssen har sammen med BLA-ansøgningen anmodet om Priority Review-status. De amerikanske sundhedsmyndigheder, FDA, vil oplyse Janssen, hvorvidt der kan tildeles Priority Review-status inden for 60 kalenderdage, efter FDA begynder deres behandling af ansøgningen - altså per dags dato.
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Forståligt nok. Det er også uheldigt at udviklingschefen forsvinder samtidigt med samtidgt med uroen omkring Kerrisdales udmeldinger.
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