I will like to see this protocol for pivotal very soon , if they still have higher efficacy with longer overlap treatment with HAART , and if they will want to conduct this way our pivotal than they could only use patients started from the beginning this way , I know couple of weeks ago it was 22..,
Maybe this will depend how efficacy will look after this 10 weeks , and decision will be done then.,
Hopefully BLA part one will be submitted very soon and soon after we will know about pivotal ..
I only know that any time I had conversation with Dr NP he said how good / positive conversations they having with FDA about mono/pivotal ,,
And in few presentations he used words , induction part and maintenance part of the study .,
If that true , study will not take much longer than 30 weeks , probably will be done at the time when combo will be approved , and they will just ask for label extension at this time for mono .
I also think that FDA will require them to have much less patients than in investigational phase 3.
This is how I see things progressing .
Maybe this will depend how efficacy will look after this 10 weeks , and decision will be done then.,
Hopefully BLA part one will be submitted very soon and soon after we will know about pivotal ..
I only know that any time I had conversation with Dr NP he said how good / positive conversations they having with FDA about mono/pivotal ,,
And in few presentations he used words , induction part and maintenance part of the study .,
If that true , study will not take much longer than 30 weeks , probably will be done at the time when combo will be approved , and they will just ask for label extension at this time for mono .
I also think that FDA will require them to have much less patients than in investigational phase 3.
This is how I see things progressing .
