Replies to post #19752 on Biotech Values

[DewDiligence]

>You are missing the point that the WHOLE purpose of Cox Regression is to clean up the data.<

And I submit that you are missing this whole point: it is incumbent upon the sponsor to run an intelligently-designed and well-balanced trial if the trial is intended to support an application for marketing.

If Cox lowers the p-value from 0.33 to 0.02, then the trial is ipso facto not intelligently-designed and well-balanced.

Has there ever been a trial accepted by the FDA as legitimate support for a marketing application where Cox lowered the p-value from 0.33 to 0.02? I don’t think there has been and I doubt there ever will be.