Thank you for the clarification. I guess I misunde
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Posted On: 04/05/2019 11:36:49 PM
Thank you for the clarification. I guess I misunderstood what others meant and/or what qualifies for supplemental label filing.
I was looking at it as drug based and not treatment based.....i.e. once leronlimab was approved for HIV all other treatments would still go through the clinical trials and everything as any drug, but approval would be a supplemental BLA from the original approval and not require a completely separate BLA filing.....meaning less paperwork, less cost, less approval time as most of the non-clinical and CMC portions would be status quo.
Safe travels if you are still away.
I was looking at it as drug based and not treatment based.....i.e. once leronlimab was approved for HIV all other treatments would still go through the clinical trials and everything as any drug, but approval would be a supplemental BLA from the original approval and not require a completely separate BLA filing.....meaning less paperwork, less cost, less approval time as most of the non-clinical and CMC portions would be status quo.
Safe travels if you are still away.
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