robbie123 schreef op 11 maart 2019 19:31:
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Hallo NielsB
Hier de transcript text
Deze tekst is van 22 feb
Lees in de 2e alinea
End of this month dat is dan toch februari als dit op 22 februari wordt gezegd door hem
Of course, we are waiting with bated breath the results of our two Phase 3 trials, FINCH 1 and FINCH 3 which will be available by the end of this quarter. Those are in more than 2,600 patients and should help us better define the risk benefits profile there and see whether our working hypothesis is actually translating into reality impact by data.
Regarding the filing of 100 versus not. So, I've also spoken about this in a number of occasions. I'm very happy with the way we design our FINCH 3 program where we fully evaluate 100 and the 200-milligram in those studies. And at the end of the -- when we have all the package with all FINCH, again by the end of this month, we will be in a much better position to make an assessment on the risk benefit profile and whether we should file with both doses, one dose and so long so forth, but it's really premature at this point to do it.
If I may, however, extrapolate from the FINCH 2 data where we studied both doses in the biological incomplete responder, so those are the more difficult to treat patients. With those when you look at the data, both on efficacy and on safety what we see is you see a very good performance of 100-milligram very competitive, but we see also a better performance of 200, so there seem to be a dose responses in terms of efficacy. But what stood out also for us is the absence of any dose dependent uptick in adverse events or safety concern.
If this profile continue to be confirmed in the FINCH 1 and Finch 3 studies, then it will be in a very good place moving forward, but again, it's premature, we'll just wait -- we need to wait another -- few more weeks to be able to get the totality of the data, but that's where we are today