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Posted On: 06/29/2020 3:47:32 PM
Post# of 148917
The conversation you are having about the Mexican trial is relevant.
25 patients with placebo will NOT produce a powered enough trial for approval if we follow FDA standards.
But this is not the FDA and the Mexicans are pragmatic (as FDA should be in these circumstances).
They will likely compare with results in the same situation(s) (that is, placebo group and Leronlimab arm).
Then use similar results from other hospitals as an "enlarged" placebo and make a decision, even with a lower power (with the trial placebo only).
And then, if the drug arm is very good, start using it no more questions asked. Their people are dying and they will not dance at the tune that FDA dances. They know that the drug is safe, they only want to know if IT WORKS.
And voila, it will be approved under any name that permits its wide use in the county.
The question will be pricing … and, not an easy question, as they will likely bargain for a reduced price. But I think CYDY will do a special deal for los Estados Unidos Mexicanos.
25 patients with placebo will NOT produce a powered enough trial for approval if we follow FDA standards.
But this is not the FDA and the Mexicans are pragmatic (as FDA should be in these circumstances).
They will likely compare with results in the same situation(s) (that is, placebo group and Leronlimab arm).
Then use similar results from other hospitals as an "enlarged" placebo and make a decision, even with a lower power (with the trial placebo only).
And then, if the drug arm is very good, start using it no more questions asked. Their people are dying and they will not dance at the tune that FDA dances. They know that the drug is safe, they only want to know if IT WORKS.
And voila, it will be approved under any name that permits its wide use in the county.
The question will be pricing … and, not an easy question, as they will likely bargain for a reduced price. But I think CYDY will do a special deal for los Estados Unidos Mexicanos.
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