Genmab — December 2018
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could it be milestone tomorow???
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Ifølge FDA's egen tidsplan for RTOR går der mere end 20 uger fra headline data til godkendelse. Derved er april ikke helt ved siden af. At det i et par tilfælde er gået hurtigere, betyder jo ikke, at det vil gå sådan hver gang. https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/OCE/ucm612927.htm
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in addition to that; it is a pilot program; i believe they will try this out with the Big Pharma, that have a lot of staff and experience with sBLA etc; so JNJ will be one of only a few that have a chance in my opinion, and Dara is their fastest growing drug, AND FDA has already goodplenty of experience with & and knowledge off Dara
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