2022 HIV-MDR now = BLA approval route ? Pa
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Posted On: 02/26/2025 12:51:10 AM
2022 HIV-MDR now = BLA approval route ?
Part of the "Abbreviated timeline"??
We always rightfully assumed BLA was for "350mg / 700mg Hiv" single treatment, anti-breakthrough.
The indication is crowded & no longer unmet need.
MDR is an unmet need.
HIV-MDR BLA application part of an Hiv Agreement?
https://www.cytodyn.com/newsroom/press-releas...or-hiv-mdr
The standard fee for a BLA submission for FY 2024 is $483,560, but there are other costs which go into the process6. The review itself is broken up into five phases: filing determination and review planning, review, advisory meeting preparation and conduct, action, and post-action.
https://www.reprocell.com/blog/what-you-shoul...on-process
BOOOM !!
Part of the "Abbreviated timeline"??
We always rightfully assumed BLA was for "350mg / 700mg Hiv" single treatment, anti-breakthrough.
The indication is crowded & no longer unmet need.
MDR is an unmet need.
HIV-MDR BLA application part of an Hiv Agreement?
https://www.cytodyn.com/newsroom/press-releas...or-hiv-mdr
The standard fee for a BLA submission for FY 2024 is $483,560, but there are other costs which go into the process6. The review itself is broken up into five phases: filing determination and review planning, review, advisory meeting preparation and conduct, action, and post-action.
https://www.reprocell.com/blog/what-you-shoul...on-process
BOOOM !!
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