Hi Saltz,
IMO Dr NP made one very big mistake..
When February 2019 we finally finished Phase 3 in combo with excellent results , 81% efficacy with 350 mg and wanted to apply for approval,
knowing that FDA approved in the past with :
45 % efficacy Maraviroc with severe side effects ,
and with 43% efficacy Ibalizumab...
He believed FDA when they told him , that we can do better than 81% with higher dose , and we will not need to do anything else just to show them 50 patients safety results for 700 mg for 24 weeks..
And Dr NP believed this story FDA gave him , this was his BIG mistake..
And we know that now every 60 days FDA asking for more , and right now they want for combo BLA ..
--all our monotherapy patients , over 500 of them , results of safety and efficacy
--and they added now even occupancy test.
If they not planning to approve both combo and mono , then something is not right here.
All imo.
My best..
News 
Market Data 
Discover 
