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Prana1

02/24/17 4:45 PM

#643 RE: gr8db8 #641

No no.
All I am trying to say is trying to reply to the original comment about - pts dropping out after suggestion from their personal doctors.

I am guessing that it did not happen on a large scale as otherwise the CRB
institutional board and DSMB - would have red flagged it.

People drop in and out of trials for a lot of reasons. But if there is a large dropout it sends the wrong signals about the selection process and how rigorously they screened the trial pts prior to enrolling.

Take a hypothetical example of a trial trying to enroll 500 pts.
If at the first go they enrolled 500 pts but as it was an open labeled trial 250 of the them receiving the avastin dropped out and of the remaining 250
In the VB 111 + avastin about 125 dropped out as they had no fever. We are left with 125.
So now they recruit again till the process goes on and on and on till all we are left is 500 of the VB 111 + avastin arm and all of them who had fever!!!
Well how is the FDA gonna like this trial.

It's an extreme example. But I hope u see what I mean.