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[posting]61856805[/posting]Wie ist deine Meinung zu folgender Frage bezüglich dem AdCom aus dem Earnings Call Transcript? „In terms of how the AdCom Panel has been set up for the December 10 and the PDUFA date just being two weeks from then, so what are the expectations there from the AdCom? How – especially, would that somehow move the PDUFA date by any means? I’m just trying to get a feel for like how your conversations are going with the FDA on the file itself, independent of the AdCom recommendation. Mark Corrigan That’s an excellent question, RK. And one that we discuss internally. I think this is really in the FDA’s court. They set up the dates. The dates are – they have the opportunity to set the AdCom. It wouldn’t be the first time that a PDUFA date has moved. I don’t think that that’s – if we have a positive advisory committee and we are engaged with the FDA in discussions with regard to labeling, I will be very pleased and I will not despair over a slip in that PDUFA date. It is a very short window for them to construct labeling. You’re right on target with that.“ https://seekingalpha.com/amp/article/4306753-correvio-pharma… |
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| aus der Diskussion: | CORV (Mkap $95 M) FDA Entscheidung in Dezember /ADCOM eventuell in November |
| Autor (Datum des Eintrages): | Jack48 (14.11.19 20:52:16) |
| Beitrag: | 15 von 212 (ID:61926701) |
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