Biotek-snakken — August 2025
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"The NDA file is essentially complete. The final electronic configuration of the file, required to
meet FDA submission standards (“publishing”), is currently ongoing. This will be completed in
two to three weeks after which the NDA will be submitted *." -
Som jeg forstår det, indsendes ansøgningen uden etableret partner (endnu). Dette skaber tidspres efter eventuel godkendelse, men styrker samtidig forhandlingspositionen betydeligt - potentielle partnere risikerer at miste adgangen til at få lukket en aftale, da andre måske kommer på banen.
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Fra debatten:
IO Biotech's fase 3 resultater https://proinvestor.com/boards/127841/ -
Desuden er det endnu engang et bevis på at deres platform kan levere. Det betyder bla at man ikke som normalt med Biotek, kan undlade at inkludere preclinical i valueringen af Saniona.. da de viser at de kan indgå partnerskab så tidligt. De er dygtige i Saniona. Ingen tvivl om det.
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ViroGates offentliggør sin halvårsrapport for 1. halvår 2025 https://proinvestor.com/investornyt/1353564/virogates-offentliggor-sin-halvarsrapport-for-1-halvar-2025
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Pharma: Får toldafklaring investorerne til at vende tilbage? https://proinvestor.com/boards/127933
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Danske Bank ser muligheder i sundhedssektoren: Hæver til "overvægt" https://proinvestor.com/investornyt/1354620/danske-bank-ser-muligheder-i-sundhedssektoren-haever-til-overvaegt
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