Well if its true that the 25 person Mexico trial d
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Posted On: 06/29/2020 3:23:51 PM
Well if its true that the 25 person Mexico trial does indeed have a placebo arm, that means that Cytodyne is not concerned about the statistical power of the 25 person trial.
This is very suprising to me that Mexico would not worry about the statistical limitatations of a 25 person trial with a 7 person placebo arm.
There is a very possible chance of failure in the leronlimab trials that just closed, and that chance is solely due to the small number of patients and is not related to the efficacy of the drug, although if the drug works 100% then the trial design probably does not matter.
So here's some wild guesses as to why 25 is ok for Mexico:
1) Mexico protocol permits combining 25 Mexico patients with the 50 interim patients from the US phase 2/3 severe/critical trial
2) USA phase 2/3 severe/criticl trial result is so good it suggests 25 is enough, and if 25 is enough, 25 is quicker than 50
3) Mexico 25 patient trial doesn't matter cuz Mexico will approve based on US trial results
4) Mexico 25 will use other endpoints besides all-cause mortality, including the clinical symptoms and Patterson blood tests. Of course if the Mexico trial is a direct copy of the US s/c then this reason would not be true.
At any rate, I think the main point is just what you said: they picked 25 for Mexico cuz they knew the US results, perhaps even they knew the intirety of the US results yesterday when the finalized Mexico.
This is very suprising to me that Mexico would not worry about the statistical limitatations of a 25 person trial with a 7 person placebo arm.
There is a very possible chance of failure in the leronlimab trials that just closed, and that chance is solely due to the small number of patients and is not related to the efficacy of the drug, although if the drug works 100% then the trial design probably does not matter.
So here's some wild guesses as to why 25 is ok for Mexico:
1) Mexico protocol permits combining 25 Mexico patients with the 50 interim patients from the US phase 2/3 severe/critical trial
2) USA phase 2/3 severe/criticl trial result is so good it suggests 25 is enough, and if 25 is enough, 25 is quicker than 50
3) Mexico 25 patient trial doesn't matter cuz Mexico will approve based on US trial results
4) Mexico 25 will use other endpoints besides all-cause mortality, including the clinical symptoms and Patterson blood tests. Of course if the Mexico trial is a direct copy of the US s/c then this reason would not be true.
At any rate, I think the main point is just what you said: they picked 25 for Mexico cuz they knew the US results, perhaps even they knew the intirety of the US results yesterday when the finalized Mexico.
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