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Re: I think we're over the hump"AndexXa is 1 of the top 5 hospital drug launches over the last 30 years" I interpret that to be Andexxa is no 5 on the list, which is fine. "Ciraparantag" Huge. Big relief, that program is at least seriously wounded. "KCentra study" Helpful, but funded by Portola, so hard to believe it will be viewed as practice changing. "C Code and NTAP" Positive developments adding fuel to the fire. "First sale in Europe." Hard to get excited when they pointedly did not name the country. I am optimistic about Europe, but I think appreciable sales are still a ways off. "Label expansion" Again, the momentum all seems to be moving in the right direction. Curious to see what FDA wants for a phase 3. Recall that A was approved over the objections of the assigned reviewers in CBER. |
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Msg # | Subject | Author | Recs | Date Posted |
6429 | Re: I think we're over the hump | theriver | 8 | 8/9/2019 12:59:08 PM |
6430 | Re: I think we're over the hump | TaiTienMuyBien | 3 | 8/9/2019 1:43:31 PM |