Zealand Pharma — Juli 2023
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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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Shortpositioner på danske aktier https://www.proinvestor.com/boards/113673
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Det er helt naturligt, hvis investorerne efter den store nedtur i sidste uge vil være tilbageholdene på købsiden, selvom de fik nyheden om FDA ansøgning fredag. Der skal nok en en eller to gode nyheder mere til før aktien vil søge over modstanden i 250 og videre op mod niveauet før faldet der startede mandag d. 26. juni.
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Næste nyhed jeg forventer at se er annoncering af fase 3 for BI. Jeg regner også at de er i dialog med potentielle partner for daciglucsgon til hyperinsulisne.
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