Genmab — April 2021
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Når genmab indsender ansøgning på basis af et fase 2 studie, sker det ikke uden forudgående konsultationer hos FDA. Og når FDA desuden tildeler PR, skal en afvisning være begrundet en alvorlig brist i datamaterialet. Det tror jeg ikke på, men det er selvfølgelig en mulighed.
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jeg har en del basis Genmab som ligger fast pga af jeg vurdere Casen er go, også har jeg en del jeg swinger med, efter tendenser og indikationer.... og ja det undgåes ikke at få en over nallerne ind i mellem , men sommetider bliver det også vældig godt.... jeg ved skattevæsnet over vejer at sende blomster og takke kort til mig, eller det burde de gør ...
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E L - I asked him about that in the PI Q/A. But he wouldn‘t give a clear guidance yet. Presume it must be coordinated with BioNTech, when the information can be passed on.
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It is probably 1046, he has not so keen to make comments about outsourced products the last couple of years
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Yes I remember that
the famous robottics technology which the competitors can‘t copy -
I surely understood it as one of Genmabs propriety programs and yes 1046 must be the best bet - its very hard to get a feeling about DR5/DR5 but if things goes well maybe that asset could go in phase III in some small indication. Another wild guess could be DuoHexaCD37 in combination with epco.
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