Genmab — Juni 2020
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Agreed EL. On month earlier possibility of income!
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*one
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Jeps
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As FDA warns on delays, a big Novartis approval stalls – coincidence? https://www.evaluate.com/vantage/articles/news/snippets/fda-warns-delays-big-novartis-approval-stalls-coincidence
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Det er per definition aldrig en positiv ting at FDA har følt sig nødsaget til at bede om flere data. Det øger risiko for de afviser den. De er ofte noget på bivirkninger og subgrupper af patienter som FDA ikke mener er godt nok belyst i det oprindelige indsendte. Så jeg vil helt sikkert sige det er en dårligere nyhed end 1 mdr hurtiger SC godkendeles af dara i EU
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