Genmab — Februar 2013
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http://www.sibbing.com/blog/en/myeloma-treatments/ flere forskellige behandlinger han har været gennem
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er der nogen der har et link til FDA´s kriterier for at give denne nye hurtige adgang til markedet?
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The Food and Drug Administration Safety and Innovation Act (FDASIA) includes a provision that allows sponsors to request that their drug be designated as a Breakthrough Therapy. FDA is in the process of developing guidance related to this designation. Until guidance is developed, requests for Breakthrough Therapy designation should follow the criteria outlined below
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tak!
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60 dage efter submission. Ikke lang tid
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Daratumumab passer som fod i hose til det program!
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Hvis man sammenholder det med hvad Paul Richardson sagde på post ASH seminaret - nemlig at mulighed for hurtig godkendelse var "very real" såfremt data var gode - og det viste man i løbet af et halvt års tid, så passer det med "primary completion date"
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Hvis ikke de søger, så gør jeg
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hahaha mads. Genialt
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der er godt smæk på idag 172k nu @gen.co
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der bliver handlet igennem nu
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316K
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