|
So it is really less a matter of repeating ADMIT with more people. That is
certainly not going to be the goal. I don’t think that would be actually desirable. I
think it is really to find a design that would allow to mimic the real life situation in
a better way—almost as if the product would be approved already and then
study clinical behaviour in real life. That is going to be the ultimate way to
dissipate the FDA’s fears that Epi proColon would only lead to replacement of
first-line screening options and not to bring additional people to screening. I am
quite convinced that there is protocols that are very doable that would actually
allow us to do this. But I would not want to discuss them in detail before having
had the conversation with the FDA on this.
Real life settings" hat man doch nur in einer post approval Studie, ich denke darauf wird es hinauslaufen. Für noch was ähnliches wie Admit 2 hätte die FDA keine Argumente, da Epi dann auf Admit 1 hinweisen kann.Sollte die FDA dennoch im Ernst wieder so was sinnloses oder ähnliches sinnloses verlangen, (und durchsetzen) sollten sich andere deutsche Firmen in Zukunft ernsthaft überlegen, eine FDA Zulassung zu beantragen...
|
| Wertung | Antworten | Thema | Verfasser | letzter Verfasser | letzter Beitrag | |
| 6 | 15.830 | EPI Übernahme - Wir halten zusammen | mad-jay | Mogli3 | 01.08.25 11:59 | |
| 21 | 20.623 | Epigenomics auf dem Weg zur FDA Zulassung?! | BoersenVTEC | JuPePo | 17.08.23 15:25 | |
| 11 | 335 | Epigenomics - Nach Kurssturz v. 60% jetzt Rebound? | Rudini | Hundlabu | 25.04.21 02:00 | |
| 17 | Abstimmung: Epigenomics-Hauptversammlung | Docci | Blauerklaus44 | 24.04.21 22:54 | ||
| 4 | CMS | Jayt91 | v0000v | 02.03.20 20:16 |