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Posted On: 02/23/2022 9:03:14 AM
Post# of 148890
Ujnfortunately the video is down so there's no way to check but it seems like the statements may be taken out of context. he letter states that conclusory statements were made but outside of "our results were very strong" statements were made based on the trial results.
Quote:
“In the United States, we did a trial of 394 patients which included severe and criticallyill population. In the critically-ill population, our results were really strong. . .”
“Our critically-ill population that we did in the United States when we gave a dose of leronlimab, the survival rate was 78%. Once we gave them another dose, the survival rate went up to 82%.”
“Imagine, if 78% went to 82, the next one would be maybe 88, and then 95. I am making up numbers, but if it goes to that kind of numbers, if it just follows the same pattern what we learned, this is going to be the most fantastic results anybody could ever imagined to have. Now I’m not saying that’s what we’re going to get, but I’m saying that’s what the results are showing.”
“The primary endpoint…is the discharge, the rate of patients who get on ventilator and get discharged. That endpoint was 166% better in our trial that we did in the United States versus placebo…166%.”
https://www.fda.gov/inspections-compliance-en...7-02112022
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