(Total Views: 346)
Posted On: 05/07/2019 11:49:26 AM
Post# of 154719
SJ , they never asked for mono FTD. , as you said it doesn’t meet criteria .
Patients do have HAART ,
but to us it will not be that important since we be asking for label expansion to our combo , if approve this is faster anyway ..
FDA can stop studies and approve at any time , but for mono pivotal , since there is other medicine , they might not . I just hope it will be no longer than 24 weeks since we already going 48 weeks with investigative mono phase 3.
Trding think it will be 48 , and we will do what will have to be done .
If positive results with our TNBC I believe it will go very fast , let’s just start .,
Anyway very important things are clearing now..
Patients do have HAART ,
but to us it will not be that important since we be asking for label expansion to our combo , if approve this is faster anyway ..
FDA can stop studies and approve at any time , but for mono pivotal , since there is other medicine , they might not . I just hope it will be no longer than 24 weeks since we already going 48 weeks with investigative mono phase 3.
Trding think it will be 48 , and we will do what will have to be done .
If positive results with our TNBC I believe it will go very fast , let’s just start .,
Anyway very important things are clearing now..
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