Personally , I believe something should be done..
But you tell me....
Our combo is for MDR HIV , dying people , and they playing with us since 2015..
First they gave us protocol when doctors in 38 hospitals and clinics couldn't enroll 40 patients within 2 years..
This may happen for 2 reasons.
-- very rare diseases.
or
--very bad protocol..
And HIV is not a very rare disease.
After 2 years finally they changed protocol and enrollment was done..
We finished study February 2019 , with 350 mg , efficacy 81%..
They approved Maraviroc with 45%
Ibalizumab with 43%..
But they told us to continue patients on 525 mg and 700 mg for 24 more weeks safety profile ,
because they expect even better results..
So again , another year passed ..
And every month as patients dying we still need more data...
It is not looking very honest to me...
I cant believe what they doing with us, as for hardly working Remdesivir they changed primary endpoint to accommodate results of the study , and approved drug 2-3 days later...
And about 70% of people approving this drug in FDA had some financial relation with Gilead..
How all this can be legal...
All IMO...