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tduggan

03/05/21 4:16 PM

#350738 RE: farrell90 #350682

The trial is not adaptive as I thought it might be. The only variation allowed is the possible extension of dosing to 5 days as previously PRed.



Farrell90, can you please explain to this woodworker how the decision would be made and by whom to extend from 3 to 5 days? Is this decided by the DMC? Who else, if anyone, has access to the same data as the DMC? Does the DMC know which patient is getting B? Lots of data must be flowing from the various trial sites to the DMC. I'm guessing the DMC must be working around the clock in order to be able to make the call to extend a patient from 3 day to 5 day.