Genmab — September 2015
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was not established (NE) as illustrated below, the data has now matured. Hence, according to Professor Voorhees,the median overall survival has now been reached and amounts to an impressive 17+months. These data have not been confirmed by the companies (J&J/Genmab),though. To put the 17+ monthsintocontext, the patients in the SIRIUS study were extremely ill and refractory with fiveprior lines of therapy, a median time from diagnosis of about fiveyears, 20% of patients hadhigh-risk genetic profi
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95% were double-refractory, and 66% were refractory to “three of the big four drugs” commonly used in myeloma. Many of the patientswere so-called end-stage myeloma patients and hence the expected overall survival is about6-9 months maximum(likely closer to six). Furthermore, when looking at the pivotal study for Amgen’s carfilzomib in less sick patients, the overall survival was 15.4 months.
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n this case, one should bear in mind that 50% of the patients in the DARA SIRUS study had also received Carfilzomib, underpinning the impressive response and survival data further. The FDA’sapproval data for DARA, based on the SIRIUS data, the Breakthrough Therapy Designation and the Priority Review is 9March, but we do not see it as unlikely with an approval already in 2015
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Link til interview (3:20min inde): https://www.youtube.com/watch?v=7Tkp88aLW1M&noredirect=1
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fedt fedt. Og slutter med "so there will be more headline news on dara? Yes definetly"
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Jeg lagde linket i debatten lørdag nat. Så er det nemmere at finde frem til: http://www.proinvestor.com/debat/73220
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Skal vi så lige tage en lukkeauktion som i fredags?
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Jeps..Men trods alt en godkendt dag.
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Det regnestykke kan vi godt lide JKY.
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Hvad dælen sker der lige i US!!!?
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forklarer det hvorfor biotekindexet er nede 4,5%?
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Ok..Det så jeg så ikke.
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Det er Hillary, den onde heks, der er efter os - http://www.cnbc.com/2015/09/21/biotech-falls-on-clinton-price-gouging-comments.html
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Vi nærmer os et fald på 5% på en time - det er sgu da seriøse sager!
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