(Total Views: 742)
Posted On: 10/31/2020 9:43:19 AM
Post# of 155367
“Multiple BP companies have failed or had less than stellar results compared to Cytodyn.” What does leronlimab need to do to escape from FDA jail and continues its mitigation successes?”
Leronlimab needs statistically significant data from the S/C trial, demonstrating a reduction in deaths, in order to be approved. The data from the EIND patients is great, but it’s anecdotal to the FDA and served only as proof of concept for the development of the S/C trial. From the point of view of the FDA, leronlimab has only improved the NEW2 score in a small trial of M2M patients.
“Does Cytodyn have to enroll and treat the full 395 patients before it is taken seriously?“
Possibly. We won’t know if the trial will require full enrollment until the second analysis by the DSMC at 293 patients. There’s been speculation that the 2nd analysis was added by the DSMC with the purpose of ending the trial early if efficacy is clear, but we don’t know that for sure. We know the DSMC wants to review the mortality rate at 42 days and we can assume they want to do so because the mortality rate is better at 42 than at 28. Again, we’ll have to wait for the decision from the 2nd analysis, but the good news is the trial was continued as designed, which indicates data is tending in the right direction.
Leronlimab needs statistically significant data from the S/C trial, demonstrating a reduction in deaths, in order to be approved. The data from the EIND patients is great, but it’s anecdotal to the FDA and served only as proof of concept for the development of the S/C trial. From the point of view of the FDA, leronlimab has only improved the NEW2 score in a small trial of M2M patients.
“Does Cytodyn have to enroll and treat the full 395 patients before it is taken seriously?“
Possibly. We won’t know if the trial will require full enrollment until the second analysis by the DSMC at 293 patients. There’s been speculation that the 2nd analysis was added by the DSMC with the purpose of ending the trial early if efficacy is clear, but we don’t know that for sure. We know the DSMC wants to review the mortality rate at 42 days and we can assume they want to do so because the mortality rate is better at 42 than at 28. Again, we’ll have to wait for the decision from the 2nd analysis, but the good news is the trial was continued as designed, which indicates data is tending in the right direction.
(7)
(0)
