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Saturday, March 27, 2021 12:47:14 PM
And DSMC advising to add patients if tey see that study will not meet primary endpoint as it is now..
And this is your 3 primary endpoint in the trial . So many times changed.
More patients is good. Fewer patients is bad. With more patients, it is easier to show statistical significance. You need to show statistical significance for an EUA. I don't make the rules. You don't make the rules. The FDA makes the rules.
Changing endpoints and adding patients is only allowed for trials that the DSMC believes are showing promise. That is good for HGEN, not bad. I realize that impatient shareholders want their trial to end as quickly as possible. But it is better to wait a bit longer and do the job right.
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