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Re: Doc logic post# 56190

Monday, 03/07/2016 12:31:11 AM

Monday, March 07, 2016 12:31:11 AM

Post# of 699483
But changing the endpoints always add to the negative list wrt the trial being well run.

And changing it after the principal investigator has gone public that she knows what is going on in the trial?

After two other trial changes (one very major)?

For a trial that has been on enrollment hold twice (at least)?

That has been running over a timespan where the prior operation tech has improved?

For a single trial with zero supporting data?

At what point would this not meet the criterion for a single trial approval?
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