Genmab — Maj 2019
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Det samme gør jeg med Zealand Pharmas nye CEO Emmanuel Dulac, når vi har Q&A med ham d. 29. maj.
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God morgen
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God morgen.
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@NoHope, 2 sjæle en tanke
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Poseida Therapeutics Reseives US FDA Orphan Drug designation for P-BCMA 101 for the treatment of MM https://m.firstwordpharma.com/poseida-therapeutics-receives-us-fda-orphan-drug-designation-p-bcma-101-treatment-multiple-myeloma
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Synes ikke der er meget RTOR over den MAIA ansøgning. Jeg ved ikke om jeg forstår den her tegning https://www.fda.gov/about-fda/oncology-center-excellence/real-time-oncology-review-pilot-program men kan det passe at Janssen completed sBLA submission den 12. marts? https://johnsonandjohnson.gcs-web.com/static-files/5cec96a8-449f-4608-8890-a83c0b00d0b9 Herfra går der ifølge FDA ca. 4 uger? nu er der så gået 8 uger.
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Winkel fra CC om RTOR og Maia: It's up to the gods at the FDA right now, but I think the process is going well, and there is no reason to be concerned at all. It's an experimental program. It's a pilot program. So the time lines are not fixed, but we expect it very, very shortly.
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