I think this goes to show that the work CytoDyn ha
Post# of 153880
(Total Views: 462)
Posted On: 10/28/2022 10:23:58 PM
Re: HHIGambler #129717
I think this goes to show that the work CytoDyn has done over the past 6 months in their valiant attempt to get the clinical hold lifted, was firstly sufficient to do just that. To get the hold lifted and with the aggregate of the safety data, Leronlimab, having met its primary endpoints in these pivotal trials, has been proven as both clinically safe and effective as validated through the External FDA Type GCP Auditing Authority.
However, the quality of the data, whether in its reporting, or monitoring capacity, just was not up to the expected par that the FDA would accept for the BLA document and would utterly fail outright simply based on the quality of the data collection.
CytoDyn's work over the past 6 months in aggregating the safety data, has gone on to prove that Leronlimab is safe and effective, yet, through the various, Internal, External and Pharmacovigilant auditors along with Mr. Dunlap, head of the auditing committee, it has been decided that the quality of the data collection would not support a successful BLA resubmission.
However, the quality of the data, whether in its reporting, or monitoring capacity, just was not up to the expected par that the FDA would accept for the BLA document and would utterly fail outright simply based on the quality of the data collection.
CytoDyn's work over the past 6 months in aggregating the safety data, has gone on to prove that Leronlimab is safe and effective, yet, through the various, Internal, External and Pharmacovigilant auditors along with Mr. Dunlap, head of the auditing committee, it has been decided that the quality of the data collection would not support a successful BLA resubmission.
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