Hansa Biopharma — Maj 2023
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""I think we owe it to the patients to help them intervene," said committee member and consumer representative Kathleen O’Sullivan-Fortin, who voted in favor. Others expressed confidence in the safety profile of the gene therapy even amid concerns about the efficacy."
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Sarepta Therapeutics Announces Positive Vote from U.S. FDA Advisory Committee Meeting for SRP-9001 Gene Therapy to Treat Duchenne Muscular Dystrophy
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Der er vist ikke særlig mange som har fanget det seneste nye omkring Sarepta og FDA. Havde forventet en noget større reaktion i dag.
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6,5% op nu….nok mange der har brændt fingrene lidt, og holder sig lidt tilbage
Lad os håbe på et lille shorts squeze kan tænde raketten -
@B.Andersen - Tror ikke at Sarepta sagen er helt hjemme endnu. Med stemmerne 8-6 er der vel stadig stor risiko for at beslutningen kan gå den forkerte vej. Men spændende bliver det.
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Mbcruise..Jeg tror at alle os der har fulgt forløbet med ekspertudvalget fredag ved, at sagen ikke er afgjort endnu. Men da ekspertudtalelser, i forbindelse med eventuel fast track til medicin i tidlig faseforsøg til alvorlige sygdomme uden anden reel god behandlingsmulighed, er eksperterne anbefaling ofte meget delte.
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8-6 i favør for Sarepta burde i den sammenhæng gøre nogen af de mange shortere nervøse. En positiv afgørelse om 14 dage vil betyde en meget stor stigning i kursen på Hansa Biopharma.
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Nye indlæg i Bents tråd: https://www.proinvestor.com/boards/112647/#112655
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Kort video: Opdatering: Zealand Pharma' Bavarian' Hansa Biopharma - Fantastisk udvikling i aktiekursen for Zealand Pharma. Det går hedt for sig i Bavarian Nordic-chatten - men hvad er selskabets business case? Hansa Biopharma afventer grønt lys til at køre videre i accelereret proces med stof inden for genterapi - og hvis det lykkes med en eventuel endelig fremtidig godkendelse, ser det for alvor godt ud for selskabet. https://www.proinvestor.com/boards/112684/
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Bioinvest..."Hansa Biopharma's enzyme cleaving technology imlifidase may potentially be used as a pre-treatment to SRP-9001 in up to 14% of the DMD patient population and if successful in both DMD and LGMD Hansa Biopharma will be eligible to receive up to USD 400 million in milestones from Sarepta Therapeutics plus up to midteens in royalty payments and sales of imlifidase.
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According to Fierce Biotech, expectations in DMD are high with SRP-9001 potentially be one of the biggest biotech product launches in 2023 with annual sales of more than USD 2 billion in less than five years". https://proinvestor.com/boards/112647/
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