Aktiesnakken — Februar 2010
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div vurdering af symptomer gennemgås.
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der var noget frygt mht. "chorea" (hvad det så er) men den viste sig ubegrundet
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Safety profile:
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Any adverse Events er lav ift.... ( i 60'erne %)
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disse inkluderer alt.
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over hele 6mdr perioden
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afhængig af hvad man måler svarer forbedringen i "motor functions" til ca. 6-15 mdr (sygdomsforløb)
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conclusion. Signifacantly improve motor functions
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no "thearapeutic disadvantages"... (no worsening of disease ... and no increased adverse events)
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Så er der Q&A.
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Novod, handelsbanken:
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any cross read to be made with HART-study i USA.... særligt 3 vs 6mdr?
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og så et spgm om timing mht. filing m.m.
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svar: studies er forskellige så svært at sige.
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start discussions med myndighederne nu
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follow up vedr. primary endpoint i HART study....
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svaret er at myndighederne ikke slaver af primary endpoints......... ergo man er flexible afhængig af resultaterne..forstår jeg det.
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spgm vedr. 1.salg... der er ikke taget nogen beslutning endnu, fordi de lige har fået data ind... men går de afsted med det, vil det kunne
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være indenfor 1.halvår
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(named patient programs formoder jeg)
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