Genmab — September 2015
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Prøv lige at regne på pct for helbredelse eller stabilisering for Dara. Gang det så med det estimerede og forventede dødstal for sygdommen i 2015 og vel ca det samme i 2016. Man forventer 11.000 døde i USA og 87.000 på verdensplan. Få det så godkendt
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Skal Dara ikke godkendes i Europa
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Er der søgt i Europa
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Her er FDAs egen glitter brochure for 2014 approvals: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DrugInnovation/UCM430299.pdf
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With a move away from general cytotoxic chemotherapy drugs with marginal efficacy findings to targeted drugs having unprecedented response rates, the review question is not whether we should approve the drug, but how quickly we can approve the drug.
These types of applications do not need to go to ODAC.
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Many drugs are vying for expedited approval, and preparations for ODAC would slow down the approval.
“In making a decision regarding whether an ODAC is necessary, we must also balance the timing of the meeting versus an expedited approval,” Pazdur said. “Our office has commonly approved important applications prior to their Prescription Drug User Fee Act goal date.
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