Genmab — April 2021
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E L and Sukker. No - my question was just about the historical relationship between the PR and the approval, as there must be some criteria met to obtain a PR. I realise that it potentially still can fail and that it, with good reason, still has to live up to the normal standards. Thank you both for replying. E L, no need to search. I trust your memory
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Og tak for link Sukker
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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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