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Posted On: 10/01/2022 8:48:21 PM
Post# of 148878
Let's see how cool, calm and collected they remain after the results of the external FDA Type GCP Audit.
The purpose of this external audit is to help to decide whether or not to re-submit the BLA and will answer the question of had Amarex done their job and originally submitted an acceptable document up to Good Clinical Practice Standards, then would the BLA for HIV have been accepted by FDA and also would Leronlimab be approved today.
When this Audit reveals that the answer to that question is a resounding Yes, the BLA for HIV would have been accepted by the FDA, Mr. Lawlor won't sleep well.
The purpose of this external audit is to help to decide whether or not to re-submit the BLA and will answer the question of had Amarex done their job and originally submitted an acceptable document up to Good Clinical Practice Standards, then would the BLA for HIV have been accepted by FDA and also would Leronlimab be approved today.
When this Audit reveals that the answer to that question is a resounding Yes, the BLA for HIV would have been accepted by the FDA, Mr. Lawlor won't sleep well.
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