Zealand Pharma — Juli 2023
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ok tak ES
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Godmorgen
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God morgen
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YPE - Den oprindelig plan var at den bi-homonelle testing skulle starte i dec 2022 men jeg har ikke set at studiet er startet endnu selvom jeg på forskellig måder har prøvet at forstå hvorfor det er forsinket. Men dette kan IR (eller Adam på QA) svarer på.
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Men jeg tror muligvis at devise accept kom senere fra FDA end oprindeligt antaget.
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Mornings
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Ifølge Finanstilsynets oversigt over aggregerede korte nettopositioner så ligger Zealand Pharma nu på 4,16 %. Det var tidligere 4,05% og det betyder altså en øgning på 0,11 %.
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Godmorgen
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God morgen
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For dem som vil vide lidt mere om hvad det er for en tkenologi, som Beta Bionics har udviklet så kan jeg anbefale følgende videeo: https://vimeo.com/841055702/0843dbad68
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Videoen har fokus på iLet devicen med et rent insulin setup men det er denne device, hvor de også jobber med at få ZP's glucagon ind. Jeg tror dette er ikke så enkelt at gøre men Beta Bionics er den type virksomhed som kan få dette til at lykkedes.
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Det som Beta Bionics har oplyst om studiet med ZP's dasiglucagon er følgende:
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System using Zealand Pharma’s dasiglucagon in adults and children 6 years and older with type 1 diabetes. The trial includes three sub-trials, which are anticipated to provide the clinical data necessary to support the market application for the bihormonal configuration of the iLet Bionic Pancreas and the new-drug application (NDA) for the use of dasiglucagon in bihormonal artificial pancreas systems.
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The first of these three sub-trials will be an initial three-month single-arm, bihormonal-only safety and test-run period that will enroll two participants at each of the approximately 30 clinical sites. A six-month, three-arm, randomized controlled trial will follow the test-run period and will enroll approximately 700 participants. A six-month extension study will immediately follow the randomized controlled trial for all of the approximately 700 participants.
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