>Why couldn't Ovation conduct the trial as if rATIII was another drug in phase II trials as opposed to waiting until FDA approval of rATIII? I understand that recruiting would be easier following approval, but it isn't a prerequisite, right?<
The ease of recruiting patients for a trial that uses an approved drug is part of the reason for waiting but not the entire reason, IMO.
Perhaps more important is the risk of running a CABG/HR trial before the FDA approves ATryn for HD. What if a patient in the CABG/HR trial experienced some kind of weird adverse event? Even if the event were not drug-related, the FDA could conceivably place a clinical hold on the entire ATryn program including the BLA for HD.
This is a low-likelihood outcome, of course, but it’s not crazy for Ovation and GTC to protect themselves from such an eventuality by waiting a few additional months to start the CABG/HR trials.
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