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Aandeel Pharming Group AEX:PHARM.NL, NL0010391025

  • 0,743 14 jun 2024 17:35
  • -0,007 (-1,00%) Dagrange 0,743 - 0,759
  • 2.937.440 Gem. (3M) 6M

24 juni - 28 juni

431 Posts
Pagina: «« 1 ... 17 18 19 20 21 22 | Laatste | Omlaag ↓
  1. [verwijderd] 28 juni 2013 14:22
    Ik weet niet wat jullie verwachten voor maandag a.s. maar die 74 dagen stonden volgens mij voor dit:

    SAN DIEGO & Leiden, The Netherlands (June 18, 2013) – Santarus, Inc. (NASDAQ: SNTS) and Pharming Group NV (NYSE Euronext: PHARM) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Biologics License Application (BLA) for the investigational drug RUCONEST® (recombinant human C1 esterase inhibitor) 50 IU/kg. Santarus and Pharming are seeking U.S. marketing approval of RUCONEST for the treatment of acute angioedema attacks in patients with hereditary angioedema (HAE). The FDA indicated that as part of its review it plans to present the BLA to the Blood Products Advisory Committee. Pursuant to the Prescription Drug User Fee Act (PDUFA) guidelines, Santarus and Pharming expect the FDA will complete its review or otherwise respond to the RUCONEST BLA by April 16, 2014.

    En dat is dus netjes binnen die 74 dagen geregeld.

    Volgend bericht verwacht op 16-4-2014 zoals je hierboven ziet.
    Sinterklaas wordt gek van wilde speculasies.
  2. [verwijderd] 28 juni 2013 14:26
    Once the application is submitted, the FDA has 60 days to conduct a preliminary review which will assess whether the NDA is "sufficiently complete to permit a substantive review". If the NDA is found to be insufficiently complete (and reasons for this can vary from a simple administrative mistake in the application to a requirement to reconduct much of the testing), then the FDA rejects the application with the issue of a Refuse to File letter which is sent to the applicant explaining where the application has failed to meet requirements.[5]

    Assuming that everything is found to be acceptable, the FDA will decide if the NDA will get a standard or accelerated review and communicate the acceptance of the application and their review choice in another communication known as the 74-day letter.[6] A standard review implies an FDA decision within about 10 months while a priority review should complete within 6 months
431 Posts
Pagina: «« 1 ... 17 18 19 20 21 22 | Laatste |Omhoog ↑

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