Given the conditions for a breach in the In-Process Review seem to be relatively clear, I am surprised Big Russ is surprised.
I'm not sure how much seasonal variations was factored into original estimates, but it seems intuitive enough that if a Phase 2 trial is heading into its third flu season its in fact way behind schedule and according to BARDA's conditions here, in breach.
The cost may not necessarily be in breach as they recruited 639 versus 636 patients but if they were allowed to continue enrolling to hit 80% powering, I hazard a guess they would be 10% overbudget in cost, again according to BARDA's conditions here, in breach.
Given the conditions for a breach in the In-Process Review seem...
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