Genmab — April 2016
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speaking of ema - der har været møde i COMP (19-21 april) og dara blev vendt - http://www.ema.europa.eu/docs/en_GB/document_library/Agenda/2016/04/WC500205027.pdf
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det ligner en mundtlig diskussion af marketing authorisation - hvor langt er vi egentlig i processen?
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check i øvrigt Empliciti lige under dara i mit link - er de ved at løbe ind i problemer ifht EMA?
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sukkeralf - fedt, hvis vi kan komme i en position til at give GSK nogle prygl
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The Committee for Orphan Medicinal Products (COMP) is the committee at the European Medicines Agency that is responsible for reviewing applications from people or companies seeking 'orphan-medicinal-product designation'
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det er vist dem, der skal give os det grønne lys
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jeg ved det ikke
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men det kunne godt tyde på det. Har du styr på, hvilken kommitte, der skal give final go-ahead, hvis ikke det er COMP?
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uuups - her er problemet i COMPs konklusion omkring Elo - In particular, significant benefit versus carfilzomib has not been justified; an indirect comparison of the results from studies CA204004 and ASPIRE pertaining to subgroup analysis, did not justify a clinically relevant advantage, such as improved efficacy or safety in the approved identical indication.
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En kritisk tråd omkring GENMAB Bull certifikater på vores facebookgruppe: https://www.facebook.com/groups/1552522675046712/permalink/1564130013885978/
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Kan anbefale alle at melde sig til gruppen. Debatten er seriøs og i voldsom vækst.
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