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misiu143

03/27/21 12:49 PM

#155076 RE: DonDonDonDon #155075

You are correct , the more patients the easer is to show SS in any study..

But the first time HGEN changed primary endpoint , it was before interim results what I remember , since it has nothing to do with DSMC.

Interim time , DSMC is evaluating what is happening during the study,,, If they will see to many side effects , or no positive effect at all , they will recommend to stop..if results unusually good , they will recommend to stop and some type of approval..

If they see some improvement and no serious side effects ..but not at this point SS results , they usually recommend to increase number of patients , and lets hope it will work for you.

All IMO..