Plavac , very good post , I have opinion about pa
Post# of 153887
(Total Views: 619)
Posted On: 02/08/2020 3:24:09 PM
Plavac , very good post , I have opinion about part 2 , and it was not Dr NP problem but FDA.
Just before end of December 2019 , Dr NP said I think during CC , or maybe beginning of January.
FDA want us to use 700 mg in combo and they just asked us for little more details here.
Later in some interview he told us those " little " details FDA wanted , they don't want only 50 patients on 700 mg but entire monotherapy study , all 595 patients , and dr Kush Dhody said this will be no problem..
But since I know how much of work this is , I am not surprise that since the time they learned about this request end of December , result might be end of February...
I will not be surprise if little later..
Part 3 , look like manufacturing company had some problems with stability test ,,hopefully will be finished soon.
IMO as always..
Just before end of December 2019 , Dr NP said I think during CC , or maybe beginning of January.
FDA want us to use 700 mg in combo and they just asked us for little more details here.
Later in some interview he told us those " little " details FDA wanted , they don't want only 50 patients on 700 mg but entire monotherapy study , all 595 patients , and dr Kush Dhody said this will be no problem..
But since I know how much of work this is , I am not surprise that since the time they learned about this request end of December , result might be end of February...
I will not be surprise if little later..
Part 3 , look like manufacturing company had some problems with stability test ,,hopefully will be finished soon.
IMO as always..
(2)
(0)