good catch by blafarm. Mexico tiral size of only 2
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Posted On: 06/29/2020 2:38:43 PM
good catch by blafarm. Mexico tiral size of only 25 patients is informed by the results of the severe/critical 50 person interim analysis, which is complete as of today.
The primary endpoint of the 50 person interim analysis severe/critical is all-cause 28 day mortality.
Well, today is day 28 (might be 29).
And don't forget that each test tube that comes into Patterson's lab has a patient identifier on it. Might as well be their name and social security number for all Petterson cares.
So Patterson knows for certain what is outcome of the severe/critical all cause mortality primary endpoint. And he knows it today.
And as of a few days ago, Patterson knew at least 45 of the 50 s/c patient outcomes because today's date is only for the last patient enrolled. The early patients are all done with the study.
So Patterson may have known the outcome of the primary endpoint on severe/critical a few days ago.
And now Mexico signs up for a 25 patient trial. My suspicion is that there is no placebo arm in this trial. The 50 patient s/c interim analysis has significant problems because the sample size is so small. Dropping to 25 patients makes a placebo arm unlikely.
I do not know what rules Mexico FDA goes by.
Maybe they picked 25 to get it done as fast as possible.
The primary endpoint of the 50 person interim analysis severe/critical is all-cause 28 day mortality.
Well, today is day 28 (might be 29).
And don't forget that each test tube that comes into Patterson's lab has a patient identifier on it. Might as well be their name and social security number for all Petterson cares.
So Patterson knows for certain what is outcome of the severe/critical all cause mortality primary endpoint. And he knows it today.
And as of a few days ago, Patterson knew at least 45 of the 50 s/c patient outcomes because today's date is only for the last patient enrolled. The early patients are all done with the study.
So Patterson may have known the outcome of the primary endpoint on severe/critical a few days ago.
And now Mexico signs up for a 25 patient trial. My suspicion is that there is no placebo arm in this trial. The 50 patient s/c interim analysis has significant problems because the sample size is so small. Dropping to 25 patients makes a placebo arm unlikely.
I do not know what rules Mexico FDA goes by.
Maybe they picked 25 to get it done as fast as possible.
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