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Posted On: 01/24/2022 5:07:00 PM
Post# of 148878
In a private message from stockguru2020, I discovered that I didn't read all of the article that I posted earlier. I should have highlighted this too.(for all the others who didn't read the entire article) Thanks SG2020.
"The biggest wildcard and risk to Tollovir is CytoDyn's leronlimab, because it has completed trials in the United States with results suggesting significant efficacy. Tollovir is considerably behind in U.S. development because no IND is in place, but it is perhaps a leg up on safety because the same active ingredient in its nutraceutical Tollovid has the FDA certificate of free sale (though leronlimab has an impeccable safety profile as well). In a Proactive video, CytoDyn's CEO said that the FDA will be willing to accept meta-analysis for its Phase 3 trial in support of a BLA filing. Meta analysis allows the combination of two or more Phase 3 trials in data analysis, and this would help CytoDyn provide proof of efficacy as their prior trial did not randomize the trial arms properly when accounting for age, which convoluted results. The company indicated another 20 patients needed to be recruited in the currently enrolling Phase 3 trial. Since this leronlimab Phase 3 trial is being conducted in Brazil where infections have recently skyrocketed, the company might be able to quickly recruit the 20 patients out of 1.5 million current infections. If this recruitment is successful, then CytoDyn could beat Tollovir to the finish line in filing for a COVID-19 EUA in the hospitalized setting. The EUA would be in critical patients, potentially still leaving the door wide open for Tollovir to carve out a niche in the severe setting. It should also be noted that leronlimab is not an antiviral; it is an immune modulator. However, in competing for treating patients, this is still relevant. "
https://www.streetwisereports.com/article/202...-lock.html
"The biggest wildcard and risk to Tollovir is CytoDyn's leronlimab, because it has completed trials in the United States with results suggesting significant efficacy. Tollovir is considerably behind in U.S. development because no IND is in place, but it is perhaps a leg up on safety because the same active ingredient in its nutraceutical Tollovid has the FDA certificate of free sale (though leronlimab has an impeccable safety profile as well). In a Proactive video, CytoDyn's CEO said that the FDA will be willing to accept meta-analysis for its Phase 3 trial in support of a BLA filing. Meta analysis allows the combination of two or more Phase 3 trials in data analysis, and this would help CytoDyn provide proof of efficacy as their prior trial did not randomize the trial arms properly when accounting for age, which convoluted results. The company indicated another 20 patients needed to be recruited in the currently enrolling Phase 3 trial. Since this leronlimab Phase 3 trial is being conducted in Brazil where infections have recently skyrocketed, the company might be able to quickly recruit the 20 patients out of 1.5 million current infections. If this recruitment is successful, then CytoDyn could beat Tollovir to the finish line in filing for a COVID-19 EUA in the hospitalized setting. The EUA would be in critical patients, potentially still leaving the door wide open for Tollovir to carve out a niche in the severe setting. It should also be noted that leronlimab is not an antiviral; it is an immune modulator. However, in competing for treating patients, this is still relevant. "
https://www.streetwisereports.com/article/202...-lock.html
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