“Reason for getting more data immediately on cri
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Posted On: 03/06/2021 12:02:11 AM
Re: onestepahead #81170
“Reason for getting more data immediately on critical population would be to give FDA more data ASAP for a full approval vs EUA.”
100% agree. What we don’t know is how many patients the FDA will require in this additional protocol that has been filed. CYDY didn’t provide the p value for the mortality endpoint nor the power of the trial, but another 100-200 may be needed based on those numbers. The OLE patients may help, but not all of those patients are critical. I’m assuming NP will provide general details about the protocol on Monday morning.
100% agree. What we don’t know is how many patients the FDA will require in this additional protocol that has been filed. CYDY didn’t provide the p value for the mortality endpoint nor the power of the trial, but another 100-200 may be needed based on those numbers. The OLE patients may help, but not all of those patients are critical. I’m assuming NP will provide general details about the protocol on Monday morning.
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