Once again: crucial things like whether or what da

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Once again: crucial things like whether or what date someone was dosed -- all missing. We know that from the FDA's letter to CYDY and Amarex.

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The FDA's letter was based on the submitted BLA. The trial sites themselves are supposed to maintain their own records. Cytodyn has not said data retrieval is impossible. Cytodyn thinks it's not worthwhile.

With Cabenuva on the market using monthly injections leronlimab's market has shrunk. Then we have to look at how long and costly it will be to retrieve all the data and reassemble it into a viable BLA. That is scarce money that Cytodyn thinks is better used for NASH.

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The decision to voluntarily withdraw was based on various factors, including systemic issues related to the quality of the data collection and monitoring of the pivotal clinical trials by the clinical research organization (CRO) contracted to manage the trials, resulting in significant concerns with achieving a successful U.S. Food and Drug Administration (FDA) BLA approval. The Company is of the opinion that FDA approval for the HIV-MDR indication is not feasible without significant additional investment to remedy the issues.
https://www.cytodyn.com/newsroom/press-releas...or-hiv-mdr

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On a side note, I was talking to someone about leronlimab as I am wont to do. When I mentioned the upcoming NASH trial she said that she had NASH and her doctor had her on a cancer drug that suppressed the immune system. Which would be helpful in lowering inflammation and slow progression of the disease. The down side is a suppressed immune system could bring on a host of other complications.