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Re: Learning53 post# 200667

Sunday, 01/16/2022 9:16:15 PM

Sunday, January 16, 2022 9:16:15 PM

Post# of 232872
"Definite improvement" is not a "real" difference. It is not clinical evidence.

The company manipulated NEWS2 data claiming it was statistically significant and it wasn't. FDA Statement said it specifically and NP admitted it wasn't finally. It is stock fraud -- false and misleading statements. It is also the basis of the first SEC and DOJ investigation and will likely be the basis of him losing his job and possibly going to jail.

Making safety claims that LL is safer than saline solution is ridiculous -- look at the TSAEs -- treatment related -- they are the same. No knowledgeable person would find a better safety than benign placebo like saline solution. The company hyped it, but it is another proof point of deceptive clinical trial data. Again -- why the SEC and DOJ is likely going to come down on NP for "false and misleading" statements. Clocks ticking.

Nobody should be given an EUA when the clinical data clearly showed it was no better than saline solution. Ridiculous.

Here's the FDA Statement that clearly contradicts the statement of a "definite improvement over placebo group:

"With the conclusion of both the CD10 and CD12 clinical trials, it has become clear that the data currently available do not support the clinical benefit of leronlimab for the treatment of COVID-19. In the smaller study that CytoDyn conducted in patients with mild-to-moderate COVID-19 disease (CD10), there was no observed effect of the drug on the study’s primary endpoint or on any of the secondary endpoints. The primary endpoint for the CD10 trial relied on a measure of participants’ COVID-19 symptoms called a “total clinical symptom score”, which was assigned based on the severity of each participant’s fever, muscle aches, shortness of breath, and cough. This score ranged from 0 (no symptoms) to 12 (all 4 symptoms present and severe). The CD10 trial results showed no clinically meaningful differences in average change in “total clinical symptom score” from baseline to Day 14 between study arms (-3.5 in the leronlimab group versus -3.4 in the placebo group). Additionally, none of the secondary endpoints were met in this study, including mortality, time to symptom resolution, and time to return to normal activity. Taken together, the CD10 results indicate that most study participants experienced resolution in COVID-19 symptoms regardless of whether they received leronlimab or placebo."
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