Genmab — April 2021
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Analytiker om dansk biotekselskab: Det kan blive en gamechanger https://www.euroinvestor.dk/nyheder/analytiker-om-dansk-biotekselskab-det-kan-blive-en-gamechanger (in case you haven't heard Millionærklubben)
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Thank you E L. A quick question. Do you know if a drug has ever been rejected after having been issued a priority review?
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Ja bussen kørte 12 Marts da vi fik macd købssignal https://nbg1.your-objectstorage.com/proinvestor-dev/forum/boards/91849_macd_buy_signal.png
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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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