Nur mal so ein Beispiel.
Nebenwirkungsprofil OK mit gleichwertiger Wirkung ist m.M nach zu wenig als allein Herrscher über Endo second line.
Einfach mal einen Schritt weiter gedacht. Werden bei Mehrfachchemos nicht auch Dosen reduziert bez. der Tox? Das ist ein wesentlicher Vorteil den sich die FDA doch bestimmt nicht entgehen lässt.
Noch mal der andere Sachse!
Richard Sachse Okay. The protocol has been discussed with FDA during a Special Protocol Assessment at the time when the study was designed. And at that point in time, the thinking was that Zoptrex would be potentially more efficacious and safer as compared to the standard therapy doxorubicin. Obviously, in an ideal world we would observe a better efficacy and a better safety, and this is what we hope for. On the other hand, there are certainly other scenarios, which might end up with a significant better efficacy, but an equal safety or vice versa. It could be a significantly better safety and equal efficacy. In all of these scenarios, we believe the product would have some potential value and the definitive criteria would still need to be discussed with FDA. We did not engage into additional discussions with FDA about specific criteria that they would want to see after the Special Protocol Assessment. We obviously had additional FDA indirections on other parameters. And as Genevieve has just reported in our financial statement, we were able to agree with FDA on our current tox programs, and we were able to save quite a significant amount of money here. But as I said, we did not engage into further discussions, this remained to be seen. We believe we would have a viable product in either case if efficacy or safety would be significantly better than doxorubicin.
http://seekingalpha.com/article/...ts-earnings-call-transcript?page=8
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