Genmab — November 2017
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16.00
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Hva´så McJean...er du stadig ude at bundgarnsfiske
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Jeg mener, at vi er fantastisk attraktive. Vi er et innovativt "powerhouse" med et godt omdømme, men fokus for selskabet er at forblive selvstændigt.
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Så der er behov for hele tiden at kommunikere med investorerne og omverden. Til syvende og sidst er det aktionærerne, der bestemmer. Den bedste beskyttelse mod et opkøb er en høj aktiekurs og en åben og transparent kommunikation med aktiemarkedet, og det er præcis, hvad jeg forsøger, siger administrerende direktør Jan van de Winkel til Ritzau
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Jefferies...de har gar forstået casen
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har
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Nå nu ser det ud til at det har stabiliseret sig, så jeg vil gå ud og nyde de 30 grader på Amadores stranden og med en kold San Miguel...bueno dias til alle
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Danske Bank mener der kan komme BTD til tisotumab vedotin i år.
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A breakthrough therapy designation can be assigned to a drug if "it is a drug which is intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition" and if the preliminary clinical evidence indicates that the drug may demonstrate substantial improvement
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over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development."[5][7]
Requests are reviewed by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). CDER receives approximately 100 requests per year for breakthrough designation. Historically, about one third were approved. CBER receives 15–30 requests per year.[8] Sponsors must apply for breakthrough
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status separately for each indication they intend to label the drug for.
Breakthrough designation applications are submitted as an amendment to the IND applications before the initiation of clinical trials.[9]
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