Aktiesnakken — September 2013
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The decision to withdraw the lixisenatide application follows discussions with the U.S. Food and
Drug Administration (FDA) regarding its proposed process for the review of interim data. Sanofi
believes that potential public disclosure of early interim data, even with safeguards, could potentially
compromise the integrity of the ongoing ELIXA study. Sanofi’s decision is not related to safety
issues or deficiencies in the NDA. -
av av av av av. Koster vel 20-30% idag !
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Det er da noget crap. man kommer med en elendig meddelelse for derefter at forklare det som en god ting ?
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jo i weekenden med 150 i kursmål
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Det værste er dog at: de siger det ikke skyldes FDA, sikkerhedsproblemer eller andet, men udelukkende at de ikke vil offentliggøre Elixa data før studiet er færdigt. Det er da bullshit?? man udskyder da ikke sin ansøgning på det vigtigste marked med 3 år uden grund ?
(basal insulin), the investigational LixiLan fixed-ratio
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