No one could foretell what will happen with FDA ,
Post# of 148184
(Total Views: 295)
Posted On: 09/19/2019 10:27:28 PM
No one could foretell what will happen with FDA , imo..
I am glad that we at the end with HIV , but things imo were not as they should be...
Many cant believe that FDA could come up with protocol when doctors in 38 hospitals and clinics had hard time to find 40 patients HIV positive ,
with MDR 2 and above , in two years..
Unfortunately HIV is not a rare disease , and in USA we have about 180K R5-HIV positive patients MDR2.....and they couldn't find 40 matching our protocol !!!!!
And now FDA making decision since April-May about the dose , and August 28 want more data with 700 mg , after saying few months ago they don't need 700 since 525 work better !!!
I am glad we at the end ...
And IMO as always.
I am glad that we at the end with HIV , but things imo were not as they should be...
Many cant believe that FDA could come up with protocol when doctors in 38 hospitals and clinics had hard time to find 40 patients HIV positive ,
with MDR 2 and above , in two years..
Unfortunately HIV is not a rare disease , and in USA we have about 180K R5-HIV positive patients MDR2.....and they couldn't find 40 matching our protocol !!!!!
And now FDA making decision since April-May about the dose , and August 28 want more data with 700 mg , after saying few months ago they don't need 700 since 525 work better !!!
I am glad we at the end ...
And IMO as always.
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