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Tuesday, February 02, 2021 4:39:46 PM
The DSMB will determine the "Safety" factor first.
Then they examine "futility" ; if the drug has some effect towards the target " Primary outcomes' listed for the Trial.
The DSMB then allows the Trial to continue or not. This is discussed with the entity sponsoring the Trial.
Releasing that Data before the Trial patients have completed their dosing causes issues with the Trial's "Power".
Excellent news is permission to 'Continue the Trial". This shows "Safety" is OK and there is "NO Futility". IE... It's working'''
JMHO...GLTA...
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