If I remeber correctly, in the HIV BLA RTF letter
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Posted On: 12/21/2022 8:07:19 AM
If I remeber correctly, in the HIV BLA RTF letter from FDA they mentioned that AMAREX had new data in their statistics from a patient who passed away a few weeks before. AMAREX f**ed up and did not even do basic data checks. When FDA could find this out with the BLA, why could AMAREX not recognize this durcing BLA preperations?
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