Also, in the manner of the FDA looking closely at

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Also, in the manner of the FDA looking closely at the data from the second half, in what way could it be tainted? - sean007

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A company could pass along to doctors that they need more of a particular type of patient. Doctors themselves could alter how they're treating patients. There is a myriad of ways.

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So assuming the new info continues to suggest that the disease can be fatal, the primary endpoint doesn't change, and CYDY is kept in the dark regarding the mortality rates of the 195 patients. Unless, of course, the DSMC stops the trial. But, at this point, I doubt that happens unless there are no deaths in the Lero arm. - Jake2212

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The DSMC would give death rates in it's broad outline to Cytodyn. Death rate being the primary outcome Cytodyn can base their decision to file regardless of the DMSC. It also wouldn't need zero deaths in the leronlimab arm for the DMSC to recommend filing. p= .05 might make them err on the side of caution, p=.03 shouldn't.