Genmab — Marts 2019
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So it took 7 weeks from initiation till full dosier. This is precisely according to the plan. From week 9 - 16. But the plan also says that now starts the PDUFA clock. If there is such a clock, I would have expected a PDUFA-date to be published as well.
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/OCE/ucm612927.htm -
i think the PDUFA date is still +6 months looking at the examples on page 13? https://www.focr.org/sites/default/files/Friends Annual Meeting Panel 3 Slides.pdf
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God morgen. :-). Ny FDA chef. https://medwatch.dk/Mennesker/article11248423.ece
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Lige en opfølgning på NICE fra i går. https://m.firstwordpharma.com/uk-myeloma-patients-offered-new-game-changing-option-second-line-treatment-through-cancer-drugs-fund
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