Zealand Pharma — Juli 2023
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Som jeg læser ODD kræver det også at der er anses som værende en ultra-rare disease, hvilket i USA er under 200.000 potentielle patienter. Der er vist omkring 7000 klassificeret ultra-rare diseases i USA, hvor kun relativ få af dem har præparater, da omkostningerne ved udviklingen er for høje ift. indtægtsmulighederne. Her spiller ODD en vigtig rolle i at "motivere" ved at give et skattefradrag mv.
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Det her er interessant hvis korrekt. "Sponsors of an orphan drug can make use of expedited Food and Drug Administration (FDA) programs such as the Fast Track, Breakthrough Therapy, and Priority Review designations, as well as the Accelerated Approval pathway and unique grant funding opportunities, such as the Orphan Products Clinical Trials Grant program."
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Milto - Med hensyn til Fast Track etc. Jeg har diskuteret det med forskellig igår. Jeg skrev i mit indlæg igår at jeg forventet at ZP ville få godkendelse rundt nytår og af samme årsager som du skriver. Men det er jeg blevet udforderet på af andre fordi Daciglucagon til rescue pennen fik afslag på fast track og derfor siger nogen at det også bliver 10 måneders godkendelsetid på denne NDA. Det var værd at spørge IR her.
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Jeg har også se på mulighed for Priority Review Voucher. ZP oplyst i 2019 følgende "Dasiglucagon has been granted a Rare Pediatric Disease designation by the FDA for
treatment of CHI in November 2019" men jeg er bange for at muligheden for at opnå en voucher forsvandt med godkendelsen af rescue pennen. -
FDA skrev følgende i Clinical Review rapporten for rescue pennen "Fast Track Designation Request - The Applicant submitted a request for Fast Track designation on January 23, 2017. The request was subsequently denied on April 13, 2017 on the basis that the clinical development program was not designed to evaluate whether the product would fulfill an unmet need for patients experiencing severe hypoglycemia compared to currently available glucagon therapies. " https://www.fda.gov/media/147791/down
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Jeg tror desværre at FDA's begrundelse også gøre sig gældende for hyperinsulisme projektet. Men som sagt det er værd at spørge IR.
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Finanstilsynet oplyst fredag eftermiddag at ZP nu er shorted med 4,10 %.
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Zealand: Søger FDA-godkendelse af Dasiglucagon til behandling af børn https://www.proinvestor.com/investornyt/1009122/zealand-soger-fda-godkendelse-af-dasiglucagon-til-behandling-af-born
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