Genmab — November 2018
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7 uger? Det jeg kan se er at sgen fik godkendelse 2 uger efter færdiggørelsen af ansøgningen. I den skematiske tidsplan her er det så 2 uger efter uge 16. https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/OCE/ucm612927.htm
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The new process, known as the Real-Time Oncology Review (RTOR) program, allows the agency to access key data prior to the official submission of the application, the FDA explained in a press release.This allows the review team "to begin their review earlier and communicate with the sponsor prior to the application's actual submission," said Richard Pazdur, MD, director of the FDA's Oncology Center of Excellence and acting director of the Office of Hematology and Oncology
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When the sponsor submits the completed application, the review team will already be familiar with the data and be able to conduct a more efficient, timely and thorough review," he continued.In this case, the RTOR enabled the FDA to approve this indication within 2 weeks, he added.The new process was launched in July. Brentuximab is the fourth approval to emerge from the RTOR, noted the manufacturer.
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Vil den godkendelsesprocedure også kunne anvendes ved sc?
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Det bliver så første gang jeg har formået at stille et spørgsmål til JW
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Husk nu at vores Q&A læses ude i den store verden.
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Det gør vores chat også. På analytics kan jeg se at den translateres til flere sprog hver dag.
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Det lyder som om det er ret sandsynligt at MAIA kommer ind under den der RTOR pilot ordning hvis der ikke er komplicerende faktorer i ansøgningen. Kan ikke lige se hvad det skulle være. Til gengæld stiller jeg mig tvivlsom overfor om så kan køre den vej. Der står vidst eksplicit at man ikke kan køre supplements med CMC ad den vej og det kan man vel næppe komme uden om med den nye formulering ...
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