Genmab — Juli 2016
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Jeg kommenterer på Børsen Play kl. 11,15.
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I morgen.
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Novod positiv og ser mulig godkendelse allerede i 2016. Tilføjer: "
Looking beyond multiple myeloma, we would not rule out the possibility of BTDs in other indications like in lymphomas, leukaemia and solid tumours, but that will of course depend on the early data when the first of that is reported later in 2016 and into 2017" -
Ritzau:Han peger på, at selskaberne først oplyser, at registreringsansøgningen er indsendt, når FDA har kvitteret for, at ansøgningspakken er, som den skal være. Det har myndighederne 60 dage til, så derfor kan registreringsprocessen godt være indledt, selv om Genmab endnu ikke har fortalt om ansøgningen. - Hvis de allerede har indsendt for omkring en måned siden, og det er derfor, at FDA giver den her status nu, så kan en godkendelse reelt set komme inden for nogle måneder, siger Michael Novod.
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Det lyder plausibelt.
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